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Medical Supplies Names: Common, FDA and HCPCS Names

Why one medical supply has a common name, an FDA product code name, a HCPCS descriptor and a GUDID name, and how to match them.

Written and maintained by CASRAI Editorial Board

Last updated

Short answer

Medical supplies names are not one vocabulary. The same item can carry a common name (what staff say), an FDA product classification name and product code (how the regulator files it), a HCPCS Level II descriptor (how it is billed when it falls outside CPT), and a device name in the FDA’s GUDID database (how the labeler registered it). Matching an item across a requisition, a purchase order, a catalogue and a regulatory record means knowing which name belongs to which system. This page is general information, not medical advice.

Why one item has several names

Each name answers a different question. The FDA’s definition of a device in section 201(h)(1) of the FD&C Act covers an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article”, so a regulatory name has to place a product inside that legal scope and a risk class. A billing name has a different job: HCPCS Level II, maintained by CMS, is “used primarily to identify products, supplies, and services not included in the CPT codes”. A database name has a third job: the FDA’s GUDID is a reference catalogue of every device carrying a unique device identifier (UDI). A staff member’s everyday word has no formal job at all, which is why it is the least reliable name to order by. For how catalogues organise these names, see how a medical supply catalog is organised.

Medical supply categories and their usual names

In everyday purchasing, names are grouped by how an item is used up. Types of medical supplies covers the split between consumables and durable equipment in detail, and the FDA risk classes that sit across both. A short vocabulary for the categories themselves:

  • Consumable (single-use or short-life) supplies: items used up in routine care or lab work, usually named by what they are (a syringe, a bandage).
  • Durable equipment: reusable items, which HCPCS Level II covers as DMEPOS when used outside a physician’s office.
  • In vitro reagents and related articles: named inside the FDA device definition, so they have regulatory names and classes like any other device.

The category word (for example “dressing” or “gloves”) is a common name. It is not a regulatory name, and it will not necessarily match a product code or a billing descriptor.

Which name appears where

Naming system What the name looks like Who maintains it Source
Common name Everyday word used on a requisition or in conversation No one; informal Not a formal naming system
FDA product classification Device name, product code, regulation number, device class, review panel, submission type (510(k), PMA, De Novo) FDA FDA Product Classification database
HCPCS Level II Alphanumeric code, one letter plus four digits, with a descriptor; identifies supplies and services outside CPT CMS CMS HCPCS page
HCPCS Level I (CPT) Five-digit numeric code for services and procedures AMA CMS HCPCS page
GUDID / AccessGUDID Device name and company name attached to a device identifier (DI) FDA FDA GUDID page

For deeper background on the billing layer see HCPCS Level II codes; for the European equivalent nomenclature see EMDN codes.

Checking a name before you order

The checklist below uses the public records described on this page. It is a way to confirm that two names refer to the same item, not purchasing advice.

  1. Write down the common name used on the requisition, and treat it as a search term only.
  2. Look the item up in the FDA Product Classification database and note the device name, product code, regulation number and device class. Most Class III devices require premarket approval (PMA) and most Class II devices require 510(k) clearance, while Class I devices, and some Class II devices, are generally exempt from FDA premarket review.
  3. Search AccessGUDID for the labeler’s device name and company name, and compare it with the catalogue entry or the purchase order line.
  4. If the item will be billed to a payer outside a physician’s office, check whether a HCPCS Level II descriptor applies, and keep it separate from the product code. The two are maintained by different bodies and describe different things.
  5. Do not treat a generic category word as a regulatory name. If records disagree, resolve it with the supplier or the manufacturer’s instructions for use.

For where this fits in a purchase workflow, see purchase orders for medical supplies.

Common misunderstandings

  • “The product code is the billing code.” They are separate systems. A product code comes from the FDA’s classification database; a HCPCS Level II code is maintained by CMS.
  • “Anything sold as a supply is a device.” The FDA decides this by the device definition and intended use, and the agency publishes a page on how to determine whether a product is a medical device.
  • “GUDID lists production details.” GUDID holds the device identifier portion of a UDI, not production identifiers.
  • “A category name is enough to order by.” Category words are common names and do not identify a specific device record.

FAQ

What are the main medical supply categories?

Commonly, consumable supplies and durable equipment, with in vitro reagents falling under the FDA device definition. See types of medical supplies for the breakdown.

Where do I find the official name of a medical device?

The FDA Product Classification database lists the device name, product code and class, and AccessGUDID lists the device name and company name for devices with a UDI.

Is a HCPCS code the same as a product name?

No. HCPCS Level II codes identify products, supplies and services for billing outside CPT, and CMS maintains them.

Sources

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