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Zimmer, Inc.

Zimmer Unique Device Identification (UDI) Regulations and GS1 Standards Implementation Center

Zimmer supports the FDA’s Unique Device Identification (UDI) regulations and GS1 standards for both product identification and utilization in e-commerce transactions. 

Zimmer is adhering to the compliance timelines and expectation as specified by the FDA’s final rule on UDI for implementing the appropriate elements and supports the healthcare industries adoption of the Global Location Number (GLN), Global Trade Identification Number (GTIN) and the Global Data Synchronization Network (GDSN).  Zimmer sees the adoption of these standards as imperative to meeting the requirements of the FDA Unique Device Identification rule.

GHX Health ConneXiontm was selected as Zimmer’s certified data pool provider and Class III products are currently synchronized and available for our trading partners via the GDSN subscription process. The timeline for moving other devices classes can be found in the table below.

Contact:   zimmerstandards@zimmer.com

Actions and Timeline

In July 2014, Zimmer began labeling products for Class III Devices under the new UDI regulations. Class II FDASIA products will transition to the new label format using a phased approach in accordance to the FDA Compliance timeline (shown below) starting early 2015. Zimmer anticipates that all U.S. sold products will have a GTIN assigned, updated labels, and (where required) direct part marking changes completed by the FDA timeline for newly manufactured products. 

 

Device

Label/GUDID/Date Format

Direct Mark (When Required)

Class III (including class III LS/LS)

Implantable Devices licensed under the PHS Act

September 24, 2014

Class III LS/LS devices must bear a permanent UDI by September 24, 2015

All other class III devices must bear a permanent UDI by September 24, 2016

Implantable

(class II)

September 24, 2015

N/A

LS/LS

(class II)

September 24, 2015

September 24, 2016

Class II

(other than I/LS/LS)

September 24, 2016

September 24, 2018

Class I or unclassified

(other than I/LS/LS)

September 24, 2018

September 24, 2020

LS/LS = life-supporting or life-sustaining
I/LS/LS = Implantable, life-supporting or life-sustaining
Direct Mark requirements apply to products that are intended to be used more than once and intended to be reprocessed before each use. Direct mark compliance dates are in addition to label/GUDID/date format compliance dates.

Label Format

A comparison of the old and new labels and patient stickers are below.  

old label big
new label big
Old label small_opt
New Label small_opt

Summary of Changes:

“Use By” Date format changed:                                   

    From: YYYY-MM   To: YYYY-MM-DD

GS1 Matrix Barcode Information:

    (01) GTIN#

    (17) Expiration Date (YYMMDD)

    (10) Lot Number

    (21) Serial Number (if aplicabale)

Downloadable GTIN Cross Reference Sheets

For your convenience, downloadable spreadsheets for the different classed products have been provided below.  

To accurately identify a product, refer to the product label that contains the product description, product ID (catalog number) or GTIN information.

IMPORTANT NOTE:

To receive updates via your GSDN Service Provider, request a subscription to Zimmer per the instructions provided under  GDSN Instructions.

GDSN Registry Instructions

GDSN is an internet-based interconnecting network of data pools and a global registry, which is known as the GS1 Global Registry. The registry enables companies to exchange standardized and synchronized supply chain data with trading partners via a Global Location Number (GLN) and receive product data, such as classification category codes, publication and effective dates, and Global Trade Item Numbers (GTIN).

The steps to access Zimmer data on the GDSN are as follows:

  1. Establish a GDSN trading partner account with a GS1 certified GDSN Data Pool provider.
  2. Submit a subscription request for Zimmer Product Information (Zimmer’s GLN: 0885836000000).
  3. Email your GLN to zimmerstandards@zimmer.com to ensure the subscription request has been received and processed.

 

Once the steps above are complete, the request will be accepted or rejected.  If accepted, the data is available to automatically import into the providers material management system.

After deciding to accept or reject a products data, Zimmer will receive a notification regarding future product data requests.

GHX Health ConneXionTM is Zimmer’s certified GDSN Data Pool provider.  GHX’s contact information is provided below.

Global Healthcare Exchange (GHX)

5:00 a.m.– 6:00 p.m., Mountain Time, Monday to Friday

1.800.YOUR.GHX (1.800.968.7449)

support@ghx.com