CONFIDENTIAL

UDI SOLUTIONSFOR DISPOSABLE MEDICAL DEVICE MANUFACTURERS

WHERE IS THIS GOING…

Region/Country AgencyUSA FDA

China SFDA

EU DG SANCO

Japan PMDA

Canada Health Canada

Brazil ANVISA

• EU Regulations 2016-2017

MEDICAL DEVICES - UDI VISIONGoal Benefit Basic Manufacturer Action

Develop a standardized system to create the unique device identifier (UDI)

• Simplify integration in a global data base

• More rapid and precise identification of medical devices

• Foundation for global secure device supply chain

• Generate your device identifier (DI)

Place UDI on product or product packaging

• Reduce medical errors• Facilitate more useful electronic

patient records• Assist in recalls

• Determine what packaging level or product regulation affects

• Print UDI compliant label on those products and/or packaging

Create and maintain a global UDI database

• Pinpoint specific device in adverse events and recalls

• Better focused and more effective FDA safety communication

• Anti-counterfeiting, diversion, and shortages

• Pinpoint specific device in adverse events and recalls

• Submit DI and other product labeling information to the GUDID database

GENERATE YOUR DEVICE IDENTIFIER (DI)

GS-1 Health Industry Business Community Council (HIBCC)

International Council for the Commonality in Blood Banking Automation (ICCBBA)

Products Medical device products Medical device products Donated blood

ID Global Trade Item Number (GTIN)14 numeric characters

Health Industry Number (HIN)Up to 27 alpha numeric characters

ISBT 12814 alphanumeric characters

Where to get info

How to get:www.gs1us.org/get-started/get-started-roadmap/1-get-a-licensed-gs1-company-prefix

How to get:www.hibcc.org/hin-system/apply-for-a-hin/

How to get:www.iccbba.org/registration-licensing/how-to-register

Basic ID Structure

Product hierarchy (0 for consumer items) indicator digit (1) + Company prefix assigned by GS-1 (6-10) digits + Item Reference no. (6-3) +Check Digit (1)

Base HIN assigned by HIBCC (6)+ Modulo 36 check digit (1) + Suffix that identifies specific ship to, alt. locations, for functional affiliations within entity (2) + Product ID (up to 18)

Facility identification number (5) +Collection year (2) + Sequence number (6) + Check digit

For US 3 Agencies are approved to issue UDI Device Identifiers (DI’s)

SUBMIT DI ALONG WITH OTHER PRODUCT LABELING INFO. TO GUDID DATABASE

• Manual structured data entry

FDA UDI Website

• Submit device information electronically via xml file

Health Level 7 Structured

Product Labeling

(HL7 SPL) File

FDA Global UniqueDevice IdentificationDatabase (GUDID)

DI

Commercial Distribution

Direct Marking Identifiers

Secondary DI

Package DI

Customer Contact

Device Status

Production Identifiers

Latex Information

MRI Safety Issues

Clinically Relevant Size

Storage Method

Sterilization Method

Pro

duct

Info

rmat

ion

DETERMINE UDI PRODUCTS AND WHERE TO MARKWhat to Mark UDI Coverage Where to Label

Medical Devices Any medical device regulated by the FDA.

Non Reusable/Implantable Medical DevicesLocated on the lowest dispensable unit which may or may not be the lowest saleable unit. Dispensable unit is identified with respect to how the end user may end up storing and using the device.

Class 1 DevicesSome Class 1 devices not required to print the UDI label but are required to register the product with GUDID. Necessary condition for exemption is a UPC code.

Reusable/Implantable Medical DevicesAny reusable or implantable device would follow the guidelines specified by the FDA for direct part mark devices.• Can be the same or different non reusable

or implantable devices• Can have barcode and/or human readable• There are exceptions please refer to FDA

site for guidance.

Accessories Any product that supports, supplements, and/or augments the performance of the FDA regulated parent device

Spare Parts Not Required

Spare parts are generally NOT covered. Any part that is neither a medical device nor an accessory to a medical device is NOT covered unless such spare parts changes the performance with regard to its already established conformity

WHAT IS REQUIRED ON THE LABELUDI= Device Identifier + Production IdentifiersUDI = DI + PI

Device Identifiers DI’s are the registered UDI index in the GUDID database

Production Identifiers (PI’s)

(Generally whatever you are doing today to control production batches and lots)

PI’s determine how a production batch is controlled. Typically a combination of s/n, batch/ot id, production date, and/or expiration date. PI does NOT stipulate new PI information.

Barcode Need to incorporate both DI and PI into the barcode. GS-1 128 or 2D Datamatrix with applicable application identifiers

Serialization Not required unless you are already doing it.

GS-1 128 AND DATAMATRIX BARCODESSome Common AI’s Description Data

00Serial Shipping

Container Code(SSCC-18)

18 digits – numeric

01 Shipping Container Code (SSC) 14 digits – numeric

02 Number of containers 14 digits – numeric

10 Batch Number 1-20 alphanumeric

11 Production Date 6 digits: YYMMDD

13 Packaging Date 6 digits: YYMMDD

15 Sell by Date (Quality Control) 6 digits: YYMMDD

17 Expiration Date 6 digits: YYMMDD

20 Product Variant 2 digits

21 Serial Number 1-20 alphanumeric

• GS-1 specifies the encoding of the barcode where specific data is parsed via application identifiers (AI’s).

• Preceding each AI is the non printable ASCII character FNC1.

• Example codes shown below.

SUMMARY OF UDI INITIATIVE FOR US FDAParameter DescriptionUnique ID Device Identifier (DI) = GTIN or Health Industry

Business Community Council (HIBCC) or International Council for the Commonality in Blood Banking Automation (ICCBBA). DI submitted to the FDA.

Serialization None required.

Aggregation None required.

Coverage Lowest dispensable unit from an end-users perspective.

Electronic Mark GS-1 2D datamatrix or GS1-128 linear codeProduction Identifier (PI) = Whatever manufacturer is using for production control; lot, S/N, production date, and or expiration date.UDI= DI + PI. Typical AI’s 01, 10, 17, and 21

Scope & Urgency Class 3Class 2 and/or implantable life supportingClass 1

09/24/201409/24/2016

09/24/2018

Class 1 General ControlClass 2 Special ControlsClass 3 Premarket Approval

Bandages, examination gloves, surgical instrumentsAcupuncture needles, infusion pumps, surgical drapesPacemakers, HIV diagnostic tests, defibrillators

MEDICAL DEVICE PACKAGINGImage Type WW Packaging

RevenueLowest Dispensable Coding Substrate

Pouches $6.7 Billion USD Direct or Label

Blister Trays $6.0 Billion USD Direct or Label

Clamshells $2.6 Billion USD Label

Bags $2.0 Billion USD Direct or Label

Carton Boxes $1.6 Billion USD Direct or Label

OEM PACKAGING AND LABELING EQUIPMENT

Pouches Bags Labels Trays BoxesOEM Equipment

• Horizontal flow wrappers

Band sealers

Label applicators Desktop printers

Medical tray sealing machines

Carton feeders In line carton print

stations Offline print

stations

Technology TTO, Laser, TIJ TIJ, TTO TTO, Laser, TIJ TIJ, CIJ, UV Laser TIJ, Laser

MI Marking and Coding Equipment

TIJ 1050SmartDateX40&X60SLC350, 150

TIJ 1050SmartDateX40&X60

SmartDateX40&X60TIJ 1050SLC350, 150

TIJ 1050 TIJ 1050SLC350, 150

CORE PRINTING TECHNOLOGIES

All technologies shown are capable of printing scannable/gradeable GS-1 Datamatrix barcodes. Adhesion, footprint, material handling, plant environment, and speed are some of the important factors in determining the appropriate recommendation.

MARK AND READ – ENSURE COMPLIANCECoLOS Terminal Dataman Scanner Insight Camera

With the CoLOS Terminal or CoLOS software both printer and camera job configurations are stored on a single HMI – no need to manage separate pieces of equipment with multiple interfaces.

Dataman scanners to validate barcode scannablitliy.

Insight cameras to validate the both barcode scannability and OCR/OCV.

ENSURE THE RIGHT MESSAGE GETS ON THE RIGHT PACKAGE AT THE RIGHT TIME

SUMMARY OF PRODUCT SOLUTIONS

Printer Only

Print UDI compliant barcode

Printer & Barcode Scanner

Print UDI compliant barcode

Barcode scanner to

validate 2D

Barcode is scannable

Printer & Vision System

Print UDI compliant barcode

Barcode scanner to

validate 2D

Barcode is scannable

OCR/OCV of text

Validation Documentation

CoLos Terminal Optional

CoLos Terminal w/ Dataman driver preferred

CoLos Terminal RequiredMark and Read Required

CoLos High Security

CONFIDENTIAL

Q&A