Device Explorer · FDA GUDID · GMDN 12082

Ice bag

A flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it i

US‑registered devices66in commercial distribution
Companies10labelers on GUDID
Single‑use14%of device records
Sterile2%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Neotech Care Inc.4568%
Vive Health Llc711%
Precept Medical Products, Inc.35%
Concordance Healthcare Solutions Llc23%
Cardinal Health 200, Llc23%
Henry Schein, Inc.23%
Customed Inc23%
Asp Global, Llc12%

Top labelers

CompanyDevicesShare
Neotech Care Inc.4568%
Vive Health Llc711%
Precept Medical Products, Inc.35%
Concordance Healthcare Solutions Llc23%
Cardinal Health 200, Llc23%
Henry Schein, Inc.23%
Customed Inc23%
Asp Global, Llc12%
Deroyal Industries, Inc.12%
Fourstar Group Inc.12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Neotech CareASP MEDICALVIVEViveHCSArctic FlexDeRoyalKERMAHenry ScheinTHERA PlusPrecept®CUSTOMEDCARDINAL HEALTH

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KYRBag, Ice58
IMEPack, Hot Or Cold, Reusable6
KYRBAG, ICE2
IMEPack, hot or cold, reusable2
ILHSplint, Hand, And Components1
OAAAid, visual, for nausea1

GMDN & GCC registration

  • GMDN code 12082 · non‑implantable
  • Single‑use 14% · sterile 2% · Rx‑only 3% · OTC 20%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many ice bag products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ice bag", from 10 companies. The largest labeler is Neotech Care Inc. with 68% of records.

Which FDA product codes apply?

KYR (Bag, Ice), IME (Pack, Hot Or Cold, Reusable), KYR (BAG, ICE), IME (Pack, hot or cold, reusable)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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