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Device Explorer · FDA GUDID · GMDN 35486

Blood refrigerator

An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, int

US‑registered devices311in commercial distribution
Companies12labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Key Scientific Inc13242%
Helmer, Inc.9430%
Qingdao Haier Biomedical Co Ltd145%
K2 Scientific, Llc145%
B Medical Systems Sarl134%
Felix Storch, Inc.124%
Follett Corporation103%
Nor-Lake, Incorporated103%

Top labelers

CompanyDevicesShare
Key Scientific Inc13242%
Helmer, Inc.9430%
Qingdao Haier Biomedical Co Ltd145%
K2 Scientific, Llc145%
B Medical Systems Sarl134%
Felix Storch, Inc.124%
Follett Corporation103%
Nor-Lake, Incorporated103%
Philipp Kirsch Gmbh41%
Thermo Electron Led Gmbh41%
Delta Development Team, Inc21%
Tactical Medical Solutions, Llc21%

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

Brand names on the register (sample)

HaierB Medical SystemsKirschICEAutonomous Portable Refrigeration UnitFollettMaster-BiltNorlakeBRIDGE™ FRIDGE RefrigeratorExpeditionary Refrigerator (xFRIDGE™)i.Series®Horizon Series™Scientific Series™HEMOVAULT by ACCUCOLDThermo ScientificThermo Scientific TSX Universal Series ULT Freez

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

FDA product codes

CodeNameDevices
KSERefrigerator, Freezer, Blood Storage406

GMDN & GCC registration

  • GMDN code 35486 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 23% · OTC 0%
  • 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.

How many blood refrigerator products are registered in the US?

311 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood refrigerator", from 12 companies. The largest labeler is Key Scientific Inc with 42% of records.

Which FDA product codes apply?

KSE (Refrigerator, Freezer, Blood Storage)

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.

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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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