# UDI Label Data Field Reference (DI, PI and GS1 Application Identifiers)

> Source: https://netray.co/tools/udi-label-data-field-reference
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A searchable table of UDI label elements: device identifier, production identifier, GS1 application identifiers, formats and label notes.

## Category

compliance-legal

## Industry

Medical Devices

## Audience

- Regulatory affairs
- Packaging engineer
- Quality engineer

## Tool

**Kind:** worksheet

**Mode:** reference

**Columns:**

#### Element

**Key:** element

**Type:** text

#### Group

**Key:** group

**Type:** text

#### GS1 AI

**Key:** gs1

**Type:** text

#### Format

**Key:** format

**Type:** text

#### Label and data note

**Key:** note

**Type:** text

**Rows:**

**Element:** UDI

**Group:** Overview

**Gs1:** n/a

**Format:** DI plus PI

**Note:** A UDI is made of a device identifier (DI) and, where applicable, a production identifier (PI).

**Element:** Device identifier (UDI-DI)

**Group:** DI

**Gs1:** (01)

**Format:** 14 digits (GTIN)

**Note:** Fixed part. Identifies the labeler and the specific version or model. Changes when a change affects the label or the device.

**Element:** Lot or batch number

**Group:** PI

**Gs1:** (10)

**Format:** Variable, up to 20 alphanumeric

**Note:** Include in the PI when the label shows a lot or batch.

**Element:** Serial number

**Group:** PI

**Gs1:** (21)

**Format:** Variable, up to 20 alphanumeric

**Note:** Include in the PI when the label shows a serial number.

**Element:** Manufacturing date

**Group:** PI

**Gs1:** (11)

**Format:** YYMMDD, 6 digits

**Note:** Include in the PI when the label shows a manufacturing date.

**Element:** Expiration date

**Group:** PI

**Gs1:** (17)

**Format:** YYMMDD, 6 digits

**Note:** Include in the PI when the label shows an expiration date. Day 00 is allowed in GS1 when no day applies.

**Element:** Basic UDI-DI (EU MDR)

**Group:** EU

**Gs1:** (8013) GMN

**Format:** Up to 30 characters

**Note:** Not printed on the label. Used in EUDAMED, certificates and the declaration of conformity to group devices.

**Element:** Human readable interpretation (HRI)

**Group:** Label

**Gs1:** n/a

**Format:** Text beside the barcode

**Note:** The plain text form of the UDI is required alongside the machine readable form.

**Element:** Automatic identification and data capture (AIDC)

**Group:** Label

**Gs1:** n/a

**Format:** Linear barcode or 2D symbol

**Note:** The machine readable form of the UDI, for example GS1-128 or GS1 DataMatrix.

**Element:** Issuing agency

**Group:** Governance

**Gs1:** n/a

**Format:** GS1, HIBCC, ICCBBA

**Note:** FDA accredits issuing agencies. Use the coding scheme of one agency for each UDI.

**Element:** HIBCC format

**Group:** Governance

**Gs1:** n/a

**Format:** Starts with +

**Note:** HIBCC labeler identification code and product data follow the plus sign.

**Element:** Package level DI

**Group:** DI

**Gs1:** (01)

**Format:** 14 digits (GTIN)

**Note:** Each package configuration, such as unit, box and case, needs its own DI.

**Element:** Labeler

**Group:** GUDID

**Gs1:** n/a

**Format:** Company name and DUNS number

**Note:** The labeler submits the device record to the FDA GUDID database.

**Element:** Brand name

**Group:** GUDID

**Gs1:** n/a

**Format:** Text

**Note:** GUDID attribute on the device record.

**Element:** Version or model number

**Group:** GUDID

**Gs1:** n/a

**Format:** Text

**Note:** GUDID attribute that distinguishes versions and models.

**Element:** Catalog number

**Group:** GUDID

**Gs1:** n/a

**Format:** Text

**Note:** GUDID attribute when the device has a catalog number.

**Element:** Direct marking

**Group:** Label

**Gs1:** n/a

**Format:** Permanent mark on device

**Note:** Devices intended for more than one use and reprocessed before each use must carry a permanent UDI on the device, subject to rule exceptions (see 21 CFR 801.45).

**Element:** Device description

**Group:** GUDID

**Gs1:** n/a

**Format:** Text

**Note:** GUDID attribute describing the device.

**Element:** Packaging quantity

**Group:** GUDID

**Gs1:** n/a

**Format:** Number

**Note:** GUDID attribute giving how many lower level units a package holds.

**Notes:** Reference only. Confirm details against the current FDA UDI rule, EU MDR Article 27 and Annex VI, and the GS1 General Specifications for your symbology. Other markets add their own rules.

## Content

**Intro:** Getting UDI label data right means knowing which fields are fixed, which change with every lot, and which only live in a database. This reference lists the elements people ask about most, with GS1 application identifiers and formats.

**Sections:**

#### How to use this reference

**Body:** Search for an element such as lot, expiry or serial and read its GS1 application identifier and format. Use the table when you design a label template, write a barcode string, map ERP fields to label fields or prepare a GUDID submission. Export the table to Excel to share it with packaging, regulatory and IT teams so everyone works from the same list.

**Bullets:**

- DI is fixed per version or model; PI changes with production
- Dates in GS1 use six digits in YYMMDD order
- Print both the human readable text and the barcode
- Use one issuing agency scheme for each UDI

#### DI, PI and the database record

**Body:** The UDI has two parts. The device identifier tells you what the device is. The production identifier tells you how this unit was made, using lot, serial, manufacturing date or expiration date, whichever apply. The data about the device lives in a regulator database, GUDID in the United States and EUDAMED in the European Union. The label links to the record through the DI, so a wrong DI breaks the link even if the barcode scans correctly.

#### ERP and label system notes

**Body:** Most ERPs store the GTIN on the item master and the lot and expiry dates on the inventory lot record. Label printing then combines them into the GS1 string. Check that the lot field length in your ERP does not exceed 20 characters, that expiry dates print as YYMMDD, and that a change to the item revision triggers a label review. Missing a DI change after a design change is one of the more common audit findings.

#### Common mistakes

**Body:** Typical errors include printing the lot in the wrong application identifier, using a date format other than YYMMDD, forgetting a package level DI, leaving the human readable text off a small label, and not updating the GUDID record when a version changes. Test every label design by scanning the barcode with a verifier and comparing the decoded string against the item and lot data.

**Cta:** If your item, lot and expiry data sit in an ERP, Netray can help build checks that compare label data to ERP master data, running on your own infrastructure.

**Faq:**

#### What is the difference between UDI-DI and UDI-PI?

**Answer:** The DI is the fixed identifier for a device version or model. The PI is the variable part that can include lot, serial number, manufacturing date and expiration date. The label shows the PI elements that apply to that device.

#### Which GS1 application identifier is the expiry date?

**Answer:** Application identifier 17 carries the expiration date in YYMMDD format. Identifier 10 carries the lot or batch, 21 the serial number and 11 the manufacturing date.

#### Is the Basic UDI-DI printed on the label?

**Answer:** No. In the EU the Basic UDI-DI is used in EUDAMED, in certificates and in the declaration of conformity to link devices to a group. It is separate from the UDI-DI that appears on the label.

#### Do I need a GTIN for every package level?

**Answer:** Each package configuration with its own contents needs its own DI. A single unit, a box of ten and a case of one hundred each get their own identifier, with the package relationships recorded in the database.

## Search terms

UDI label data fields, UDI label template, UDI device identifier production identifier, GS1 application identifiers medical device, GUDID data elements, UDI-DI format, UDI lot expiry GS1 AI 10 17, EU MDR UDI requirements

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