GUDID Data Elements Reference Table - 3!27!17

March 27, 2017 GUDID Data Elements Reference Table
Data Element Description Data Entry Notes Edit Rules Required in Data Type Entry List of New DI Publicly
After Grace Database? 2 & Length 3 Values (LOV) Trigger Released?
Period 1
When a GUDID attribute appears in the medical device labeling, the values submitted to the GUDID should match the value in the labeling.
Device Information
Device Identifier (DI) Information
Issuing Agency Organization accredited by FDA Choose a value from the drop down None Required NA GS1; HIBCC; Yes Yes
to operate a system for the LOV. ICCBBA
issuance of UDIs.
Primary DI An identifier that is the main Enter the Device Identifier (DI) None Required Type: NA Yes Yes
Number (primary) lookup for a medical Number. Num. or
device and meets the Data type and field length are Alphanum.
requirements to uniquely determined by the individual Issuing
identify a device through its Agency structure. Length:
distribution and use. The min-6,
primary DI number will be GS1: Numeric (Num.), DI may be 12, max-23*
located on the base package, 13 or 14 digit numeric value. System
which is the lowest package will append zeros to the left or *defined by
level of a medical device beginning of DI to save 14 digit Issuing
containing a full UDI. For value, include the check digit as part Agency
medical devices without of the DI structure.
packaging, the primary DI HIBCC: Alphanumeric (Alphanum.),
number and full UDI may be on with 6-23 characters, DO NOT
the device itself. include the check digit as part of the
DI
ICCBBA: Alphanum., with 10 or 16
characters
Device Count Number of medical devices in Enter the number of devices. None Required Type: Num. NA Yes Yes
the base package.
Example: Length: 7
Base Package = Box of 100 gloves;
Primary DI = 101;
Device Count = 100.
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Period 1
Unit of Use DI An unmarked identifier assigned Enter the Unit of Use DI Number. Edit Conditionally Type: NA No Yes
Number to an individual medical device Must be from same Issuing Agency Required* Num. or
when a UDI is not labeled on as Primary DI. Alphanum.
the individual device at the level *If Device
of its unit of use. Its purpose is Unit of Use DI is an identifier used by Count >1. Length:
to associate the use of a device hospital staff and Materials min-6,
to/on a patient. The Unit of Use Management to account for a single max-23*
DI does not appear on the label device when the UDI is labeled on a
of the device. higher level of packaging. The Unit *defined by
of Use DI does not appear on the Issuing
label. Agency
Data type and field length are structure.
determined by the individual Issuing
Agency structure.
GS1: Num., DI may be 12, 13 or 14

digit numeric value. System will
append zeros to the left or beginning
of DI to save 14 digit value, include
the check digit as part of the DI
HIBCC: Alphanum., with 6-23
characters, DO NOT include the
check digit as part of the DI
characters
If Device Count = 1, cannot add Unit

of Use DI Number.
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Period 1
Labeler DUNS Business number ISSUEd by Dun Choose appropriate DUNS Number Edit* Required NA Labeler DUNS No No
Number & Bradstreet (D&B) that is used from drop down LOV. LOV
to associate the Labeler *Other
(Company) name and address to To ensure data consistency for the Labeler
a given version of model of a GUDID, DUNS number submitted to DUNS listed
device in GUDID. the GUDID should associate to the to your
company name that appears on the GUDID
device label; ideally the address account
associated with the DUNS number can be
should also match the address on the selected.
device label, but since address is not No edits of
displayed to the GUDID public user, DUNS info
this is not a requirement for data will be
consistency. permitted.
All edits to information connected to
the Labeler DUNS Number must be
done through Dun & Bradstreet. No
edits of DUNS information will be
permitted in the GUDID.
Company Name Company name associated with Auto populated based on the Labeler NA Auto NA NA No Yes
the labeler DUNS Number DUNS Number Populated
entered in the DI Record.
The labeler company name
submitted to the GUDID should
match the company name on the
device label.
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Period 1
Company Company physical address Auto populated based on the Labeler NA Auto NA NA No No
Physical Address associated with the labeler DUNS Number Populated
DUNS Number entered in the DI
Record. Ideally, this address should match
the labeler address as shown on the
device label but since this data
element is not displayed to the
GUDID public user, this is not a
requirement for data consistency.
Brand Name The Proprietary/Trade/Brand Enter the Brand Name. None Required Type: NA Yes Yes
name of the medical device as Alphanum.
used in device labeling or in the Only symbols, and will be
catalog. This information may 1) supported for the current production Length: 80
be on a label attached to a release of GUDID. NOTE: per Edit
durable device, 2) be on a Rules, you will not be able to change
package of a disposable device, or (if entered) after the Grace
or 3) appear in labeling Period.
materials of an implantable Enter NA if the device does not have
device. The brand name is the a Brand Name.
name that is typically registered
with USPTO and have the
and/or TM symbol.
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Period 1
Version or Model The version or model found on Enter the Version or Model. None Required Type: NA Yes Yes
the device label or Alphanum.
accompanying packaging used Version/Model can be any
to identify a category or design distinguishing string of letters and/or Length: 80
of a device. The version or numbers.
model identifies all devices that Catalog Number can be entered if
have specifications, device does not currently have a
performance, size, and Version or Model. If the device does
composition within limits set by not have a version, model or catalog
the labeler. number, enter a concept that can be
used to identify all devices that have
specifications, performance, size, and
composition within limits set by the
labeler.
Catalog Number The catalog, reference, or Enter the Catalog or Reference Add Optional Type: NA No Yes
product number found on the Number. Delete Alphanum.
device label or accompanying Edit
packaging to identify a Catalog Number is critical for UDI Length: 80
particular product. adoption in electronic health
records. Please provide catalog
number as part of your device
record.
Catalog/Reference number can also

serve as Version/Model if it
represents the devices that have
specifications, performance, size, and
composition within limits set by the
labeler.
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Period 1
Device Additional relevant information Enter device description. Add Optional Type: NA No Yes
Description about the device that is not Delete Alphanum.
already captured as a distinct Device description should include Edit
GUDID data attribute. any description found on the device Length:
label to support user comparison of 2000
the device label to the GUDID device
record. Otherwise, include any
additional description or text found
in the device labeling.
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Period 1
Commercial Distribution
DI Record Indicates the date the DI Record Choose date from calendar or None Required Type: Date NA No Yes
Publish Date is published and available via manually enter date in format yyyy- Format
Public Search. mm-dd. (yyyy-mm-
dd)
This date determines the Grace
Period, presently set to 30 calendar Length: 10
days. Grace Period starts the day
after the DI Record Publish Date. We
recommend you set this date to be a
future date to allow time to ensure
accurate data entry.
Commercial Indicates the date the device is Choose date from calendar or Add Optional Type: Date NA No Yes
Distribution End no longer offered for manually enter date in format yyyy- Delete Format
Date commercial distribution by the mm-dd. Edit (yyyy-mm-
labeler on record. See 21 CFR dd)
807.3(b) for exceptions. The
device may or may not still be Length: 10
available for purchase in the
marketplace.
Commercial Indicates whether the device is Auto populated based on NA Auto NA In No Yes
Distribution in commercial distribution as Commercial Distribution End Date. If Populated Commercial
Status defined under 21 CFR 807.3(b). no Commercial Distribution End Date Distribution;
is entered, the status is 'In Not in
Commercial Distribution' Commercial
Distribution
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Period 1
Alternative or Additional Identifiers
Direct Marking (DM) Direct Marking (DM) data elements only apply to devices subject to 21 CFR 801.45.
Device Subject The device is exempt from Select checkbox if appropriate. Add Conditionally Type: NA No Yes
to Direct Direct Marking requirements Delete Required* Boolean
Marking (DM), under 21 CFR 801.45. Labeler should select the checkbox Edit
but Exempt Device Subject to Direct Marking *If device is
(DM), but Exempt only if the device: subject to
(1) is intended to be used more than 801.45
once and (2) is intended to be
reprocessed before each use, but
also (3) meets any one of the
exception criteria outlined under 21
CFR 801.45(d). If the device is not
required to be directly marked under
21 CFR 801.45(a), then this box
should not be checked.
DM DI Different Indicates that the DM DI Select checkbox if appropriate. Add Conditionally Type: NA No Yes
from Primary DI Number is different than the Delete Required* Boolean
Primary DI Number. Edit
*If device is
subject to
801.45
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Period 1
DM DI Number An identifier that is marked Enter Direct Marking DI Number. Add Conditionally Type: NA No Yes
directly on the medical device Must be from same Issuing Agency Delete Required* Num. or
and is different than the Primary as Primary DI. Edit Alphanum.
DI Number; only applicable to Data type and field length are *If device
devices subject to Direct determined by the individual Issuing subject to Length:
Marking requirements under 21 Agency structure. 801.45 min-6,
CFR 801.45. and 'DM DI max-23*
GS1: Num., DI may be 12, 13 or 14 Different from
digit numeric value. System will Primary DI' is *defined by
append zeros to the left or beginning checked Issuing
of DI to save 14 digit value, include Agency
the check digit as part of the DI structure.
characters
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Period 1
Secondary DI
Issuing Agency Name of Secondary DI Issuing Choose a value from the drop down None Optional NA GS1; HIBCC; No Yes
agency. LOV. ICCBBA;
NDC/NHRIC
Secondary DI An identifier that is an alternate Enter Secondary DI Number. Add Optional Type: NA No Yes
Number (secondary) lookup for a If your product is labeled with a UDI Num. or
medical device that is issued from more than one issuing agency Alphanum.
from a different issuing agency (for regulatory or marketing reasons),
than the primary DI. you must choose one issuing agency Length:
Under 21 CFR 830.40(a), only as the Primary DI and enter the other min-6,
one device identifier from any issuing agency information here, as a max-23*
particular system for the Secondary DI.
issuance of UDIs may be used to *defined by
identify a particular version or Data type and field length are Issuing
model of a device. determined by the individual Issuing Agency
Agency structure. structure.
GS1: Num., DI may be 12, 13 or 14 digit
numeric value. System will append zeros
to the left or beginning of DI to save 14
digit value, include the check digit as
part of the DI
HIBCC: Alphanum., with 6-23 characters,
DO NOT include the check digit as part
of the DI
characters
NDC: Numeric (Num.), DI must be 10 or
11 digits in 3 segments with 2
hyphens.Valid formats for 10-digit values
are XXXX-XXXX-XX, or XXXXX-XXX-XX, or
XXXXX-XXXX-X.The valid format for an 11
digit value is XXXXX-XXXX-XX
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Period 1
Previous DI
Issuing Agency Name of Previous DI Issuing Autopopulated based on the None Optional NA GS1; HIBCC; No Yes
agency. Previous DI entered ICCBBA;
NDC/NHRIC
Previous DI Device Identifier assigned to a Enter Previous DI Number. Add Optional Type: NA No Yes
Number version/model of a medical The Previous DI must exist as a Edit Num. or
device prior to the assignment published Primary DI in another Alphanum.
of a new/substitute device GUDID device record.
identifier to that same version Length:
or model, without any changes min-6,
to the device itself, due to Data type and field length are max-23*
merger and acquisition activity. determined by the individual Issuing
Agency structure. *defined by
Issuing
GS1: Num., DI may be 12, 13 or 14 Agency
digit numeric value. System will structure.
append zeros to the left or beginning
of DI to save 14 digit value, include
the check digit as part of the DI
characters
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Period 1
Package DI Every device package shall bear a UDI, 21 CFR 801.20(a)(2). Package DIs do not need their own DI record; instead package information
should be entered in the Package DI section of the Primary DI record for that device. According to 21 CFR 801.3, a package is defined as
a fixed quantity of a particular version or model of a device.
Package DI A device identifier for the Enter Package DI Number. Must be from Add Conditionally Type: NA No Yes
Number package configuration that same Issuing Agency as Primary DI. Data Required* Num. or
contains multiple units of the type and field length are determined by Alphanum.
base package (does not include the individual Issuing Agency structure. *If device is
shipping containers). GS1: Num., DI may be 12, 13 or 14 digit available in Length:
numeric value. System will append zeros
to the left or beginning of DI to save 14 higher levels min-6,
digit value, include the check digit as of packaging max-23*
part of the DI
HIBCC: Alphanum., with 6-23 characters, *defined by
DO NOT include the check digit as part Issuing
of the DI Agency
ICCBBA: Alphanum., with 10 or 16 structure.
characters
Examples:
Box of Gloves = DI 101
4 Boxes of Gloves (DI 101) in a Carton =
Package DI 201 (the UDI on the Carton)
5 Cartons (Pkg DI 201) in a Case =
Package DI 301 (the UDI on the Case)
10 Boxes of Gloves (DI 101) in a Carton =
Package DI 202 (the UDI on the Carton).
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Period 1
Quantity per The number of packages with Enter the number of devices per Add Conditionally Type: Num. NA No Yes
Package the same Primary DI or Package package. Required*
DI within a given packaging The quantity of a package Length: 9
configuration. configuration must be >1. *If Package DI
is entered
Examples:
Package Carton, Pkg DI 201
contains 4 boxes of DI 101; the
quantity per package is 4.
Package Case, Pkg DI 301 contains
5 cartons of Pkg DI 201; the quantity
per package is 5.
Package Carton, Pkg DI 202
contains 10 boxes of DI 101; the
quantity per package is 10.
Contains DI The Primary DI for the base Choose a value from the drop down Add Conditionally NA DI numbers; No Yes
Package package or the Package DI for LOV. Required* base package
any lower level package and all lower
configuration contained within a Examples: *If Package DI levels of
given package configuration. Package DI 201 (Carton) contains is entered packaging
base package DI 101.
Package DI 202 (Carton) contains
base package DI 101.
Package DI 301 contains lower level
Package DI 201 (Carton).
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Period 1
Package Type Text to describe the outer Enter name or description of Add Optional Type: NA No Yes
packaging of the product and package. Alphanum.
enables users to understand This field is free text. There is no
higher level packaging implied definition or standard Length: 20
configurations. quantity to any package name.
Package Indicates the date this particular Choose date from calendar or Add Conditionally Type: Num. NA No Yes
Discontinue Date package configuration is manually enter in format yyyy-mm- Required* (date
discontinued by the labeler. dd. format)
*If Package DI
Discontinuation of a package is Number and Length: 10
directly related to the Commercial
discontinuation of the primary DI of Distribution
the base package. However, a End Date are
package can also be discontinued entered, must
without the discontinuation of the also enter
base package. Package
Discontinue
Date
Package Status Indicates whether the package Auto populated based on Package NA Auto NA In No Yes
is in commercial distribution as Discontinue Date. If Package DI and Populated Commercial
defined under 21 CFR 807.3(b). related elements are entered and no Distribution;
Package Distribution End Date is Not in
entered, the status is 'In Commercial Commercial
Distribution.' Distribution
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Period 1
Customer Contact
Customer Phone number for the Customer Enter phone number. Add Conditionally Type: Num. NA No Yes
Contact Phone contact; to be used by patients For North American numbers, type Delete Required*
and consumers for device- 10-digit number with or without Edit Length: 10
related questions. punctuation. *ONLY (North
For international numbers, start with required if American
"+" and type number without Customer numbers);
punctuation. Contact Email 20 (all
is entered others)
This phone number could be the 1-
800 number that appears on the
device labeling or the company
website. Labelers can identify a
Customer Contact phone number
and Customer Contact email address
for each device record.
If an email is entered and you don't
have a Customer Contact phone
number, please enter '9999999999'
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Period 1
Customer Email for the Customer contact; Enter email address. Add Conditionally Type: NA No Yes
Contact Email to be used by patients and Delete Required* Alphanum.
consumers for device-related This email address could be the same Edit
questions. one that appears on the device *ONLY Length: 100
labeling or the company website. required if
Labelers can identify a Customer Customer
Contact email and a Customer Contact Phone
Contact phone number for each is entered
device record.
If a phone number is entered and
you don't have a Customer Contact
email, please enter 'xx@xx.xx'
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Period 1
Device Status
Human Cell, Indicates that the product Select checkbox if DI record is for a Add Optional Type: NA No Yes
Tissue or Cellular contains or consists of human product defined under 21 CFR Delete Boolean
or Tissue-Based cells or tissues that are intended 1271.3 Edit If no data is
Product (HCT/P) for implantation, provided, 'No'
transplantation, infusion, or If checked, the labeler must assign is stored
transfer into a human recipient and label each HCT/P device with a
as defined under 21 CFR 1271.3. distinct identification code, per 21
CFR 1271.290(c). The distinct
identification code may take the form
of a Donation Identification Number
(DIN) , serial number, lot number, or
a combination of these production
identifiers (PIs). Labelers of HCT/Ps
regulated as medical devices should
select the appropriate type of PI that
appears on the label of the device.
Kit Indicates that the device is a Select checkbox if DI record is for a None Optional Type: NA Yes Yes
convenience, combination, in kit. Do not check if the device is a Boolean
vitro diagnostic (IVD), or constituent part of a kit. If no data is
medical procedure kit. Kits are provided, 'No'
a collection of products, is stored
including medical devices, that
are packaged together to
achieve a common intended use
and are being distributed as a
medical device.
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Period 1
Combination Indicates that the product is Select checkbox if DI record is for a None Optional Type: NA Yes Yes
Product comprised of two or more combination product. Do not check Boolean
regulated products that are if the device is a constituent part of a If no data is
physically, chemically, or combination product. provided, 'No'
otherwise combined or mixed is stored
and produced as a single entity;
packaged together as a single
package; or packaged separately
for the intended use together as
defined under 21 CFR 3.2(e). At
least one of the products in the
combination product must be a
device in this case.
Premarket
Device Exempt FDA Premarket submission is Select checkbox if FDA has by None Conditionally Type: NA No Yes
from Premarket not required for this device. regulation exempted this device from Required* Boolean
Submission premarket submission requirements;
or for pre-amendment devices that *Premarket
are not subject to premarket Submission
submission requirements. Number OR
exempt status
If left unselected, a 'No' is stored and fulfills
a Premarket Submission Number regulatory
should be entered below. requirement.
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Period 1
FDA Premarket Number associated with the Enter current FDA Premarket Add Conditionally Type: NA No No
Submission regulatory decision regarding Submission Number(s). Required* Alphanum.
Number the applicants legal right to Each DI record represents a version
market a medical device for the or model of a device. For each DI *Premarket Length: 8
following submission types: record, you must submit the original Submission
510(k), De novo, PMA, PDP, premarket authorization number and Number OR
HDE, BLA, and NDA. the supplement number through exempt status
which you obtained approval or fulfills
clearance for the version or model regulatory
identified in the DI record, as requirement.
required by 830.310(b)(11). FDA
Premarket Numbers should be
verified with the FDA PMA or 510(k)
database to make sure the Number
represents the subject of the device
record. Device records should be
updated with additional numbers in
the future, as needed.
Example: De novo #123456 should

be entered as 'DEN123456.'
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Period 1
Supplement Number assigned by FDA to a Enter all valid Supplement Numbers. Add Conditionally Type: Num. NA No No
Number supplemental application for Each DI record represents a version Required*
approval of a change in a or model of a device. For each DI Length:
medical device with an record, you must submit the original *Premarket CDRH -
approved PMA, HDE, or PDP. premarket authorization number and Submission min-1,
the supplement number through Number OR max-3
which you obtained approval for the exempt status
version or model identified in that DI fulfills CBER -
record, as required by 830.310(b) regulatory min-1,
(11). Although not all PMA requirement. max-4
supplements are applicable to a
given model or version, if FDA
approves a subsequent supplement
applicable to that version or model,
the GUDID DI record must be
updated with that supplement
number, in accordance with 21 CFR
830.330(b). 30 day notice
supplements should be submitted
ONLY if the 30 day notice impacts
the device design specifications, or
performance of the finished devices.
Do not enter alpha characters.
Example: Supplement 4 should be
entered as 004.
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Period 1
FDA Product Code
Product Code Classification for devices issued Enter all applicable Product Codes, Add Conditionally Type: Alpha FDA Product No Yes
by the FDA. three-letter code. Delete Required* Code list
For all PMA and 510k devices, Edit Length: 3
Product Codes are assigned in the *Unless
FDA approval or clearance letter, device is a kit
respectively. For Class I and exempt or IVD with a
devices, the device Product Code BL premarket
may be self-identified. submission
number
Product Code Name associated with the Auto populated based on 3-letter NA Auto NA NA No Yes
Name three-letter Product Code. Product Code Populated
FDA Listing
FDA Listing Number assigned by FDA during Enter all relevant listing numbers that Add Conditionally Type: NA No No
Number Registration and Listing to all enable the labeler to commercially Required* Alphanum.
devices in commercial distribute the given version or model
distribution, regardless of pre- of device. *Unless Length: 7
market authorization Listing number is optional for HCT/P device is an
requirements per 21 CFR devices with a BLA premarket HCT/P with a
807.28(f). number. BL premarket
submission
number
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Period 1
GMDN
Code GMDN Preferred Term (PT) Enter all applicable GMDN Preferred Add Required GMDN -- NA No No
Code is a unique five-digit code Term Codes or FDA PT Codes. Delete Type: Num.
used to identify common device Edit Length: 5
types. This PT Code is assigned Each device record must have at least
to medical devices and related one assigned GMDN Code/FDA PT FDA PT
health care products for the Code; DI records are allowed >1 GMDN Code: Type:
purposes of grouping and Code/FDA PT Code, if necessary. Must Alpha
categorization. enter GMDN Code OR FDA PT Code, Length: 4
please don't enter both codes for the
same GMDN Name and Definition.
For GMDN Codes: Enter only the 5-

digit number, omit the 'P'
For FDA PT Codes: Enter the 4-letter
code.
The FDA PT Codes are assigned to each

GMDN term, used in place of a GMDN
Code. They enable labelers to assign a
GMDN term to their GUDID submission
until a GMDN Code can be obtained
from the GMDN Agency. The FDA PT
Codes can be found in the Find FDA PT
Code Module on the GUDID website.
For more information, see the GUDID
Final Guidance. The FDA PT Codes can
be found in the Find FDA PT Code
Module on the GUDID website.
Name Name of the common device Auto populated based on GMDN NA Auto NA NA No Yes
type associated with the GMDN Preferred Term Code/FDA PT Code. Populated
Preferred Term Code/FDA PT
Code.
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Period 1
Definition Definition of the common Auto populated based on GMDN NA Auto NA NA No Yes
device type associated with the Preferred Term Code/FDA PT Code. Populated
GMDN Preferred Term
Code/FDA PT Code.
Device Characteristics
For Single-Use Indicates that the device is Choose Yes/No from the drop down None Required Type: Yes/No Yes Yes
intended for one use or on a list. Boolean
single patient during a single
procedure.
Production Identifier(s) in UDI
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Period 1
Lot or Batch The number assigned to one or Choose Yes/No from the drop down Add Required Type: Yes/No No Yes
Number more device(s) that consist of a list. Delete Boolean
single type, model, class, size, Edit
composition, or software For stand-alone software, select Yes
version that are manufactured to indicate that the software version
under essentially the same number will be represented as a Lot
conditions and that are or Batch number
intended to have uniform
characteristics and quality
within specified limits.
This number is required to be
part of the UDI when included
on the label in order to provide
the means to track the device
back to its manufacturing
source or otherwise allow the
history of the device
manufacturing, packaging,
labeling, distribution and use to
be determined.
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Period 1
Manufacturing The date on which a device is Choose Yes/No from the drop down Add Required Type: Yes/No No Yes
Date manufactured. list. Delete Boolean
Edit
This date is required to be part
of the UDI when included on
the label in order to provide the
means to track the device back
to its manufacturing source or
otherwise allow the history of
the device manufacturing,
packaging, labeling, distribution
and use to be determined.
Serial Number The number that allows for the Choose Yes/No from the drop down Add Required Type: Yes/No No Yes
identification of a device, list. Delete Boolean
indicating its position within a Edit
series.
This number is required to be

part of the UDI when included
on the label in order to provide
the means to track the device
back to its manufacturing
source or otherwise allow the
history of the device
manufacturing, packaging,
labeling, distribution and use to
be determined.
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Period 1
Expiration Date The date by which the label of a Choose Yes/No from the drop down Add Required Type: Yes/No No Yes
device states the device must or list. Delete Boolean
should be used. Edit
This date is required to be part

of the UDI when included on
the label in order to provide the
means to track the device back
to its manufacturing source or
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Period 1
Donation The Donation Identification Choose Yes/No from the drop down Add Required Type: Yes/No No Yes
Identification Number is applicable to devices list. Delete Boolean
Number that are also regulated as Edit
HCT/Ps and is a number that is This PI is only applicable to HCT/P
assigned to each donation. products regulated as medical
devices.
This number/code is required to
be part of the UDI when
included on the label in order to
provide the means to track the
device back to its
manufacturing source or
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Period 1
Latex Information
Device required Indicates that the device or Choose Yes/No from the drop down None Required Type: Yes/No Yes Yes
to be labeled as packaging contains natural list. Boolean
containing rubber that contacts humans as
natural rubber described under 21 CFR
latex or dry 801.437. Choosing 'Yes'
natural rubber indicates that the device label
(21 CFR or packaging contains one of
801.437). the following statements: (1)
"Caution: This Product Contains
Natural Rubber Latex Which
May Cause Allergic Reactions",
(2) This Product Contains Dry
Natural Rubber", (3) Caution:
The Packaging of This Product
Contains Natural Rubber Latex
Which May Cause Allergic
Reactions" or (4) "The Packaging
of This Product Contains Dry
Natural Rubber".
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Period 1
Device labeled Indicates that natural rubber Select checkbox if appropriate. Add Optional Type: NA No Public
as "Not made latex was not used as materials Delete Boolean
with natural in the manufacture of the Only applicable if the response to Edit If no data is
rubber latex" medical product and container "Device required to be labeled as provided,
and the device labeling contains containing natural rubber latex or dry "No" is stored
this information. Only natural rubber" is "No".
applicable to devices not
subject to the requirements Optional element for labelers who
under 21 CFR 801.437. Not all include a statement of 'latex-free' on
medical products that are NOT their label or in their labeling. FDA
made with natural rubber latex finds these statements: 'latex-free'
will be marked. and 'does not contain latex', to be
not scientifically supportable and
strongly recommends they not be
used in medical product labeling.
Instead FDA recommends the use of
the statement 'Not made with
natural rubber latex."
It is not assumed that all devices NOT
made with natural rubber latex are
marked; therefore this is an optional
element for the labelers who choose
to make a statement in the labeling.
Prescription Status
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Period 1
Prescription Use Indicates that the device Select checkbox if appropriate. Add Optional Type: NA No Yes
(Rx) requires a prescription to use. Can select both Rx and OTC for one Delete Boolean
DI record. Edit If no data is
provided,
"No" is stored
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Period 1
Over the Counter Indicates that the device does Select checkbox if appropriate. Add Optional Type: NA No Yes
(OTC) not require a prescription to use Can select both Rx and OTC for one Delete Boolean
and can be purchased over the DI record. Edit If no data is
counter (OTC). provided,
"No" is stored
MRI Safety Status

What MRI safety Indicates the MRI Safety Choose a value from the drop down Edit* Required NA MR Safe, Yes Yes
information does Information, if any, that is LOV. MR Unsafe,
the labeling present in the device labeling. *ONLY if MR
contain? Please see the ASTM F2503-13 The final rule does not require MRI- changing Conditional,
standard for more information. compatibility testing; it only requires from Labeling does
submission of information regarding 'Labeling not contain
MRI-compatibility that the labeler does not MRI Safety
already possesses. contain' information
to other
MR status
(Safe,
Unsafe,
Conditional
).
Otherwise,
NO
changes
are
allowed.
31 of 45
Period 1
Clinically Relevant Size
Size Type Dimension type for the clinically Choose a value from the drop down Add Conditionally NA Circumferenc No Yes
relevant measurement of the LOV. Required* e; Depth;
medical device. Device Size
If the desired Size Type is not in the *If device is Text, specify;
current list, select 'Size Text, specify' available in Catheter
and the data element 'Size Type Text' more than Gauge; Outer
will appear (see below). It is one size Diameter;
expected that the 'Size Text, specify' Height;
will only be available for a limited Length;
time. Use this option to help us build Lumen/Inner
a list of values that are appropriate Diameter;
for your device type. GUDID Needle
reserves the right to review all Gauge; Total
suggestions before adding values to Volume;
the Size Type LOV. Width;
Weight;
More than one Size Value per Type Pressure; Pore
and more than one Size Type may be Size;
added to each DI record. Area/Surface
Entry Example - 8cm by 2 cm - Area; Angle
requires 2 entries
Entry 1 - Size Type = Length,
Size Value = 8, Size Unit of Measure =
Centimeter
Entry 2 - Size Type = Width,
Centimeter
32 of 45
Period 1
Size Value Numeric value for the clinically Enter numeric value for size. Add Conditionally Type: Num. NA No Yes
relevant size measurement of Decimals are accepted; fractions are Required*
the medical device. not accepted. Each Size Value should Length: 40
be entered separately. GUDID is not *Required if
accepting Size Value as a range at device is
this time. available in
more than
Entry Example - 8cm by 2 cm - one size
requires 2 entries
Entry 1 - Size Type = Length,
Centimeter
Entry 2 - Size Type = Width,
Centimeter
33 of 45
Period 1
Size Unit of The unit of measure associated Choose a value from the drop down. Add Conditionally NA For length: No Yes
Centimeter;
Measure with each clinically relevant size. Required* Decimeter; Feet;
Entry Example - 8cm by 2 cm - Femtometer; Inch;
requires 2 entries *Required if Kilometer; Meter;
Micrometer;
Entry 1 - Size Type = Length, device is Millimeter;
Size Value = 8, Size Unit of Measure available in Nanometer;
Picometer; Yard;
= Centimeter more than For area: Square
Entry 2 - Size Type = Width, one size centimeter; Square
Size Value = 2, Size Unit of Measure foot; Square inch;
Square meter;
= Centimeter Square millimeter
For weight: Gram;
Kilogram;
Microgram;
Milligram; Metric
Ton; Pound; Ton
For total volume:
Centiliter; Cubic
Inch; Cup; Deciliter;
Femtoliter; Fluid
Ounce; Gallon;
Kiloliter; Liter;
Microliter;
Milliliter; Nanoliter;
Picoliter; Pint;
Quart
For gauge: French;
Gauge
For angle: Degree
For pressure:
Pound per Square
Inch; millibar;
KiloPascal; Hertz
34 of 45
Period 1
Size Type Text Additional undefined device size Enter Size Type, Size Unit and Unit of Add Conditionally Type: NA No Yes
not represented in the GUDID Measure for each entry. Required* Alphanum.
Size Type LOV.
*Required if Length: 200
'Size Text,
specify' is
selected
above
Storage and Handling

Storage and Indicates storage and handling Choose a value from the drop down Add Optional NA Handling No Yes
Handling Type requirements that are required LOV. Delete Environment
for the device including Edit Atmospheric
temperature, humidity, and Conditions of the Storage and Pressure;
atmospheric pressure. Handling Type are measured below Handling
Environment
as a range, with a Low Value and a Humidity;
High Value. More than one Storage Handling
and Handling Type can be added per Environment
device record. Temperature;
Special Storage
Conditions;
Storage
Environment
Atmospheric
Pressure;
Storage
Environment
Humidity;
Storage
Environment
Temperature
35 of 45
Period 1
Low Value Indicates the low value for Enter a number for Low Value. Add Conditionally Type: Num. NA No Yes
storage and handling Delete Required*
requirements. Must enter at least one value, Low or Edit Length: 6
High but can enter both Low Value *One value
and High Value, if needed. (Low or High)
is required if
When Storage and Handling value is Storage and
a range, this is the lower end of that Handling Type
range is added to
When Storage and Handling value is the device
less than a value, enter the number record
here
When Storage and Handling value is
exactly a value, enter the value here
and in Storage and Handling High
Value
36 of 45
Period 1
High Value Indicates the high value for Enter a number for High Value. Add Conditionally Type: Num. NA No Yes
storage and handling Delete Required*
requirements. Must enter at least one value, Low or Edit Length: 6
High but can enter both Low Value *One value
and High Value, if needed. (Low or High)
is required if
When Storage and Handling value is Storage and
a range, this is the higher end of that Handling Type
range is added to
When Storage and Handling value is the device
greater than a value, enter the record
number here
When Storage and Handling value is
exactly a value, enter the value here
and in Storage and Handling Low
Value
37 of 45
Period 1
Unit of Measure The unit of measure associated Choose a value from the drop down Add Conditionally NA Degrees No Yes
with the storage and handling LOV. Delete Required* Celsius;
conditions. Edit Degrees
*Required if Fahrenheit;
Storage and Degrees
Handling Type Kelvin;
is added to Kilo Pascal;
the device Percent (%)
record Relative
Humidity;
Millibar
Special Storage Indicates any special storage Enter any other storage conditions. Add Conditionally Type: NA No Yes
Conditions requirements for the device. For devices kept at room Delete Required* Alphanum.
temperature, or other standard Edit
conditions, input that information *Required if Length: 200
here. 'Special
Storage
Conditions' is
selected
above
38 of 45
Period 1
Sterilization Method
Device Packaged Indicates the medical device is Choose Yes/No from the drop down None Required Type: Yes/No Yes Yes
as Sterile free from viable list. Boolean
microorganisms. See ISO/TS
11139. The two Sterilization Method
questions are independent of each
other; this element is designed to
capture information about the device
as it enters Commercial Distribution.
These data elements are not
designed to capture sterilization
procedures executed by the
manufacturer or labeler.
39 of 45
Period 1
Requires Indicates that the device Choose Yes/No from the drop down None Required Type: Yes/No Yes Yes
Sterilization requires sterilization prior to list. Boolean
Prior to Use use.
The two Sterilization Method
questions are independent of each
other; this element is designed to
capture information about the device
before it can safely encounter a
patient, regardless of whether the
device is single use or reused after
reprocessing. These data elements
are not designed to capture
sterilization procedures executed by
the manufacturer or labeler.
If answered 'Yes', at least one
Sterilization Method (below) must be
selected.
40 of 45
Period 1
Sterilization Indicates the method(s) of Choose a value from the drop down Add Conditionally NA Chlorine No Yes
Method sterilization that can be used for LOV. Delete Required* Dioxide; Dry
this device prior to device use Edit Heat;
on the patient. Only applicable if the answer to *if 'Requires Ethylene
'Requires Sterilization Prior to Use' is Sterilization Oxide; High
'Yes'; otherwise, the LOV will remain Prior to Use' is Intensity Light
inactive. marked 'Yes' or Pulse Light;
High-level
Note that the sterilization method Disinfectant;
must be applied by the user prior to Hydrogen
device use on patient. Peroxide;
Liquid
The Entry LOVs represent the Chemical
sterilization methods recognized by Sterilization;
the CDRH Infection Control Branch. Microwave
Methods selected should be only Radiation;
those approved for each device by Moist Heat or
the CDRH Office of Device Steam;
Evaluation. Nitrogen
Dioxide;
Ozone;
Peracetic
Acid;
Radiation;
Sound Waves;
Supercritical
Carbon
Dioxide;
Ultraviolet
Light
41 of 45
Period 1
Footnotes
1 Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO
edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are auto-populated fields whose
information depends on another data element
2 See 21 CFR 830.310 and 830.340 for required data elements.

3 Alpha = alpha only; Num. = numeric; Alphanum. = alphanumeric; Date Format = enter as yyyy-mm-dd; NA = data elements with a
checkbox or LOV that dont require text entry
4 Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each
submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option.
5 Acronyms Used-- 510(k)-Premarket Notification, Alphanum.-Alphanumeric, BL-Biologic Licensing (Application), DEN-De novo, DI - Device
Identifier, GMDN-Global Medical Device Nomenclature, HDE-Humanitarian Device Exemption, LOV-List of Values, Num.-Numeric, PDP-
Product Development Protocol, PMA-Pre Market Authorization
42 of 45
April 14, 2016 GUDID Data Elements Reference Table - Change Log
GUDID Data Elements Reference Table
Change Log
Note: All changes appear in order with the most recent date shown first. For previous changes, scroll to the
bottomDate
of the list. Data Element Change
Primary DI Updated Data Entry Notes to indicate when to include
check digit as part of DI in GUDID
Unit of Use DI Slight tweaks to the definition to add more clarity
Secondary DI Changed "Edit Rules after Grace Period" column to

read -- "Add"
Secondary DIs may now be added to GUDID after the
DI record grace period
Catalog Number Updated Data Entry Notes to read - Catalog Number is

critical for UDI adoption in electronic health records.
Please provide catalog number as part of your device
record.
Previous DI Issuing Agency Added new row

Previous DI Added new row
Unit of Use DI Updated description to indicate that Unit of Use DI is
an unmarked device identifier that does not appear on
the label of the device
Added a new column titled "Publicly Released" --

indicates data element values that are released to the
public on AccessGUDID and OpenFDA
April 14, 2016 Commercial Distribution End Date Updated description to read as follows -- Indicates the
date the device is no longer offered for commercial
distribution by the labeler on record. See 21 CFR
807.3(b) for exceptions. The device may or may not
still be available for purchase in the marketplace.
Secondary DI Number Added NDC/NHRIC as an Issuing Agency type along

with data type and length
Listing Number Updated Data Entry Notes and Required Columns to
show that Listing Number is optional for HCT/P devices
with a BL premarket number.
Sterilization Method Updated description to read as follows -- Indicates the

method(s) of sterilization that can be used for this
device prior to device use on the patient.
Updated Data Entry notes
May 1, 2015 Version or Model Number Updated Length = 80

Catalog Updated Length = 80
43
Change Log
Note:
MayAll1,changes
2015 appear in order with the most recent date shown first. For previous changes, scroll to the
bottomDate
Commercial Distribution End Date Updated Description to read as follows -- Indicates the
date the device is no longer held or offered for sale by
the labeler on record. See 21 CFR 807.3(b) for
exceptions. The device may or may not still be
available for purchase in the marketplace.
January 12, 2015 Unit of Use DI Number Updated Data Entry Notes to indicate -- Must be from
same Issuing Agency as Primary DI.
DM DI Number Updated Data Entry Notes to indicate -- Must be from
Package DI Number Updated Data Entry Notes to indicate -- Must be from
Customer Contact Email Updated Data Entry Notes to change email address
from "xxx@xxx.xxx" to -- If a phone number is entered
and you don't have a Customer Contact email, please
enter 'xx@xx.xx'
Premarket Submission Supplement Updated Data Type & Length Column from Length = 4
Number digits to Length = CDRH 1-3 digits, CBER 1-4 digits
GMDN Code Added information about FDA PT Codes to Data Entry

Notes
Production Identifiers in UDI - Lot or Updated description
Batch, Manufacturing Date, Serial
Number, Expiration Date, Donation
Identification Number
Size Unit of Measure Updated Entry List of Values Column -- Added Millibar
for pressure; Removed -- Microgram per Total Volume;
Milligram per Total Volume
Storage and Handling Low Value Added to Data Entry Notes -- When Storage and
Handling value is a range, this is the lower end of that
range
When Storage and Handling value is less than a value,
enter the number here
When Storage and Handling value is exactly a value,
enter the value here and in Storage and Handling High
Value
44
Change Log
Note: All changes appear in order with the most recent date shown first. For previous changes, scroll to the
bottomDate
Storage and Handling High Value Added to Data Entry Notes -- When Storage and
Handling value is a range, this is the higher end of that
range
When Storage and Handling value is greater than a
value, enter the number here
When Storage and Handling value is exactly a value,
enter the value here and in Storage and Handling Low
Value
Storage and Handling Unit of Measure Updated Entry List of Values Column -- Added Millibar
for Storage and Handling Pressure
45

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March 27, 2017 GUDID Data Elements Reference Table

GS1: Num., DI may be 12, 13 or 14

If Device Count = 1, cannot add Unit

Catalog/Reference number can also

Example: De novo #123456 should

For GMDN Codes: Enter only the 5-

The FDA PT Codes are assigned to each

Production Identifier(s) in UDI

This number is required to be

This date is required to be part

MRI Safety Status

Storage and Handling

2 See 21 CFR 830.310 and 830.340 for required data elements.

Secondary DI Changed "Edit Rules after Grace Period" column to

Catalog Number Updated Data Entry Notes to read - Catalog Number is

Previous DI Issuing Agency Added new row

Added a new column titled "Publicly Released" --

Secondary DI Number Added NDC/NHRIC as an Issuing Agency type along

Sterilization Method Updated description to read as follows -- Indicates the

May 1, 2015 Version or Model Number Updated Length = 80

GMDN Code Added information about FDA PT Codes to Data Entry

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