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Device Explorer · FDA GUDID · GMDN 35704

Blood plasma freezer

An electrically-powered device intended to be used to store and/or transport blood plasma while keeping it frozen (temperatures of or below -18° Celsius). It typically includes internal shelving for storage and easy location of plasma containers (e.g., bags);

US‑registered devices98in commercial distribution
Companies8labelers on GUDID
Single‑use8%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Helmer, Inc.3132%
Biotecno Industria E Comercio Ltda2323%
B Medical Systems Sarl1616%
Qingdao Haier Biomedical Co Ltd1010%
Follett Corporation88%
Nor-Lake, Incorporated88%
Felix Storch, Inc.11%
K2 Scientific, Llc11%

Top labelers

CompanyDevicesShare
Helmer, Inc.3132%
Biotecno Industria E Comercio Ltda2323%
B Medical Systems Sarl1616%
Qingdao Haier Biomedical Co Ltd1010%
Follett Corporation88%
Nor-Lake, Incorporated88%
Felix Storch, Inc.11%
K2 Scientific, Llc11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Haier BiomedicalHaierB Medical SystemsFollettMaster-BiltNorlakeHelmerFARRARHorizon Series™i.Series®HEMOVAULT by ACCUCOLDK2 Scientific, LLCBiotecno

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 Storage148
KSEREFRIGERATOR, FREEZER, BLOOD STORAGE8
JRMFreezer3

GMDN & GCC registration

  • GMDN code 35704 · non‑implantable
  • Single‑use 8% · sterile 0% · Rx‑only 1% · OTC 22%
  • 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 plasma freezer products are registered in the US?

98 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood plasma freezer", from 8 companies. The largest labeler is Helmer, Inc. with 32% of records.

Which FDA product codes apply?

KSE (Refrigerator, Freezer, Blood Storage), KSE (REFRIGERATOR, FREEZER, BLOOD STORAGE), JRM (Freezer)

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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