F4: Regulatory Guide/Glossary

  • F1 Use Cases for UDI
  • F2 Uses of UDI Data
  • F3 IT Integration
  • F4 Selecting Scanners
  • F5 Regulatory Guide/Glossary

  • C1 Benefits of Scanning at POC
  • C2 Which Barcode to Scan
  • C3 Handling Scan Failures

  • SC1 Adding UDI to ERP
  • SC2 Using UDI in EDI
  • SC3 Managing UDI-DI Changes
  • SC4 Using UDI in Inventory Management
  • SC5 Using UDI in Contract Management

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    This guide will provide definitions for Unique Device Identifier (UDI) related terminology.

    • AccessGUDID: API used to electronically access information contained in Global UDI Database (GUDID).
    • Advanced Ship Notice (ASN): Shipper originated data containing complete information about the shipment and its contents. The EDI Transaction set is referred to as an 856.
    • Bill-To: Mailing address where paper invoices are sent. This can include third party accounts payable operations. The preferred option is to use the 810 EDI transaction set in place of paper invoices.
    • EDI: Electronic Data Interchange is the exchange of business information using a standardized format; a process that allows the supplier to electronically send information to the receiver of the product or service as opposed to using a less efficient method such as e-mail, fax or paper.
    • EHR: Electronic Health Record
    • EMR: Electronic Medical Record
    • ERP: Enterprise Resource Planning system.
    • Global UDI Database (GUDID): Manufacturers are required to populate this database with information related to the medical device. Some data elements are mandatory, and others are optional. The information can assist in providing follow-up treatment and enhance analytics. Examples include MRI compatibility, whether the device contains latex, and GMDN classification.
    • GPOs: Group Purchasing Organizations
    • Invoice: A supplier-initiated document detailing the services performed or the product delivered. It provides how the receiver of the service or product will generate a remittance. The EDI Transaction set is referred to as an 810
    • Issuing Agencies: There are 3 agencies authorized by the Food and Drug Administration (FDA) to provide the UDI: GS1, the Health Industry Business Communications Council (HIBCC) and the International Council for Commonality in Blood Bank Automation (ICCBBA).
    • Location Identifier: Standard way of identifying locations. They are either allocated from a GS1 Company Prefix to form a GS1Global Location Number (GLN) or issued by HIBCC using a Health Industry Number (HIN). Location Identifiers are allocated to legal entities, physical locations, and functional departments.
    • Payer: Party responsible for initiating and tracking remittances. In the case of a vendor collection call, the vendor will reach out to the payer party.
    • Price/Sales Catalog File: A commercial document issued by the seller that contains pricing and product information such as UDI-DI, unit of measure, packaging string, contract start and end date, and other information agreed upon by trading partners. This document provides a means for health care providers to synchronize their item master data with supplier data. The EDI Transaction set is referred to as an 832.
    • Purchase Order (PO): A commercial document and first official offer issued by a buyer to a seller, indicating types, quantities, and agreed prices for products or services. The EDI Transaction set is referred to as an 850.
    • Purchase Order Acknowledgement (POA): A commercial document issued by the seller to the buyer confirming the receipt of a purchase order to buy goods or services. The POA can be either fully acknowledged with no deviations or partially acknowledged.
      It allows both parties to agree upon what the buyer is requesting and what the seller is committing to provide prior to shipping and billing. The EDI Transaction set is referred to as an 855.
    • Remit To: The physical mailing address location to which a payment associated to an invoice should be sent. The preferred option is to use a Location Identifier.
    • Ship-To: The ship-to location as noted on the originating purchase order. Ideally, these should be represented as the minimum necessary address required by the delivering carrier. The preferred option is to use a Location Identifier.
    • Ship From: The warehouse/distribution physical mailing address location from which the ordered goods were sent/shipped out to the recipient. The preferred option is to use a Location Identifier.
    • Sold-To: Legal entity creating the Purchase Order. This is the corporate entity named in the Master Contract.
    • Unique Device Identifier (UDI): A full UDI is composed of the UDI-DI plus any relevant UDI-PI.
    • Unique Device Identifier (UDI-DI): A unique numeric or alphanumeric code specific to a device version or model. This is a manufacturer provided value issued by GS1, HIBCC or ICCBBA. GS1 refers to the value as a Global Trade Identification Number (GTIN), the HIBCC value is called a HIBC UDI-DI and the ICCBBA value is called the Processor Product Identification Code (PPIC). A unique code is assigned for each unit of measure. In the United States, the FDA requires manufacturers to register the UDI-DI in the Global Unique Device Identification Database (GUDID).
    • Unique Device Identifier Production Identifier (UDI-PI): Numeric or alphanumeric codes that identify production data for a device and can include batch or lot number, serial number, expiration date, manufacture date, and for human cell, tissue, cellular, or tissue based product (HCT/P) regulated as a medical device, the distinct identification code that allows the manufacturer to associate the HCT/P with the donor. If these are not required for a specific medical device, then UDI-PI will not be included in the packaging UDI barcode.

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