UDI Questions:

Base Package vs. Device Package? (CrAg Kit = 1 tube = 50 strips)

o South Africa kit = 2 tubes?
Device Identifier (DI) Information
Issuing Agency
Primary DI Number
Device Count
Unit of Use DI Number
Labeler DUNS Number
Company Name
Company Physical Address
Brand Name Version or Model
Catalog Number Device Description
Commercial Distribution

DI Record Publish Date

Commercial Dist. End Date

Commercial Dist. Status

Alternate or Additional Identifiers Direct Marking but Exempt

DM DI Different from Primary DI
DM DI Number Secondary DI Issuing Agency Secondary DI Number Package DI Number
Quantity per Package Contains DI Package Package Type Package Discontinue Date Package Status
Customer Contact

Customer Contact Phone

Customer Contact Email

Device Status HCT/P Kit Combination Product

Premarket Exempt Premarket Submission Number
Supplement Number Product Code Product Code Name
FDA Listing Number GMDN Code
GMDN Name GMDN Definition
Device Characteristics For Single Use Lot or Batch Number Manufacturing Date Serial Number
Expiration Date HCT/P Number
Labeled as contains latex Labeled as not made with latex Rx
MRI Safety Label Size Type Size Value
Size Unit of Measure Size Type Text
Storage & Handling Type
Low Value
High Value Unit of Measure Special Storage Conditions
Device Packaged as Sterile Sterilize Before Use Sterilization Method

OTC

Lab
eler Data Entry (LDE) User Role what kind of information needs to be
entered on a day to day basis? Each different lot produced? Etc.

ABOUT A UNIQUE DEVICE IDENTIFIER

A UDI is composed of two parts:

Device Identifier (DI) - A unique numeric or alphanumeric code specific to a

device version or model.

Production Identifier(s) (PI) - Numeric or alphanumeric codes that identify

production information for a device and can include the following:

The lot or batch number;

The serial number;

The expiration date;

The date the device was manufactured;

For a Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

regulated as a device, the distinct identification code that allows the manufacturer
to associate the HCT/P to the donor.
Therefore, UDI = DI + PI.
UDIs are created based on international standards for unique identification. Private
organizations, called "Issuing Agencies", are accredited by the FDA to operate a
system for the issuance of UDIs based on these standards.
A unique device identifier (UDI) on a device label appears in both plain text and in
machine-readable format. Below is an example of a unique device identifier (UDI)
from GS1, one of the FDA-accredited issuing agencies. It uses a 1D barcode for its
machine-readable format.

Human Readable Barcode:

(01)12345678901234(17)140102(11)100102(10)A1234(21)1234
In GS1's system, the numbers in the parentheses indicate the different parts of the
UDI.
Device Identifier (DI) - 12345678901234
Production Identifiers (PI):

Expiration Date: 140102

Manufacturing Date: 100102

Lot Number: A1234

Serial Number: 1234

ABOUT GUDID

The Global Unique Device Identification Database (GUDID - pronounced "Good

ID") is a database administered by the FDA as part of the UDI system.
The GUDID contains device identification information submitted by device
companies to the FDA. The GUDID contains ONLY the Device Identifier (DI), which
serves as the primary key to obtain information in the database. Production
Identifiers (PI) are not submitted to or stored in the GUDID, but GUDID data
indicates which PIs are on the device label.
Many data elements in the GUDID correspond to information on the medical device
label. The figure below shows a fictitious medical device label and identifies the
GUDID data elements that appear on the label. Please refer to the FDA UDI
website for more information about GUDID data elements.