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Device Explorer · FDA GUDID · GMDN 38569

Blood transfusion set, non-exchange

An intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip

US‑registered devices384in commercial distribution
Companies24labelers on GUDID
Single‑use100%of device records
Sterile88%labelled sterile
Prescription53%Rx‑only share
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Share of device records

Codan Us Corporation10628%
Icu Medical, Inc.10427%
B. Braun Medical Inc.3810%
Charter Medical, Ltd.257%
Baxter Healthcare Corporation164%
North American Rescue, Llc123%
Bound Tree Medical, Llc123%
Safeguard Us Operating, Llc123%

Top labelers

CompanyDevicesShare
Codan Us Corporation10628%
Icu Medical, Inc.10427%
B. Braun Medical Inc.3810%
Charter Medical, Ltd.257%
Baxter Healthcare Corporation164%
North American Rescue, Llc123%
Bound Tree Medical, Llc123%
Safeguard Us Operating, Llc123%
Bd Switzerland Sàrl113%
Altitude Technologies Inc.92%
Puriblood Medical Co., Ltd.72%
Fresenius Kabi Ag62%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BD SmartSiteMINDRAYPuribloodVolumat™ LineBlood Component Filter Set with Vented Spike andFenwal Y-Type Blood Comp. Recipient Set with StdFenwal Blood Comp. Recipient Set with Std. BloodBlood Administration SetIV Administration SetICU Medical, Inc.ICU MedicalForwardLifeFlow PLUS Blood & Fluid InfuserLifeFlow Replacement Blood Tubing SetsLifeFlow Blood InfuserTMM-FBTK-FTX (Tactical Medical Module-Field Bloo

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

FDA product codes

CodeNameDevices
FPASet, Administration, Intravascular122
FPASet, administration, intravascular83
FMGStopcock, i.V. Set56
FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALV52
BRZSet, Blood Transfusion45
POQBlood Transfusion Kit42

GMDN & GCC registration

  • GMDN code 38569 · non‑implantable
  • Single‑use 100% · sterile 88% · Rx‑only 53% · 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

Length (Inch) · 26Total Volume (Milliliter) · 1Length (Centimeter) · 1

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

How many blood transfusion set, non-exchange products are registered in the US?

384 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood transfusion set, non-exchange", from 24 companies. The largest labeler is Codan Us Corporation with 28% of records.

Which FDA product codes apply?

FPA (Set, Administration, Intravascular), FPA (Set, administration, intravascular), FMG (Stopcock, i.V. Set), FJK (SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALV)

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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