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Device Explorer · FDA GUDID · GMDN 35441

Cardiopulmonary bypass system blood tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood

US‑registered devices15,430in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Livanova Usa, Inc.5,32935%
Terumo Cardiovascular Systems Corporation5,20434%
Medtronic, Inc.4,68130%
Datascope Corp.1371%
Novosci Corp.490%
Spectrum Medical Srl170%
Maquet Cardiopulmonary Ag30%
Temed20%

Top labelers

CompanyDevicesShare
Livanova Usa, Inc.5,32935%
Terumo Cardiovascular Systems Corporation5,20434%
Medtronic, Inc.4,68130%
Datascope Corp.1371%
Novosci Corp.490%
Spectrum Medical Srl170%
Maquet Cardiopulmonary Ag30%
Temed20%
Xenios Ag20%
Hnm Stainless, Llc.20%
Angiodynamics, Inc.20%
Michigan Critical Care Consultants, Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TEMEDHLS SetNovalung Ultimate Kit (U.S.)Novalung SystemNAIntersept® Custom Tubing PackCustom Perfusion SystemINTERSEPT®HNM MedicalPerfusion PackCardioplegia PackCardioplegia PackCardiplegia PackCardiopelgia PackPrime SetPurge Line

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

FDA product codes

CodeNameDevices
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypa5,199
DWETUBING, PUMP, CARDIOPULMONARY BYPASS2,747
DTZOXYGENATOR, CARDIOPULMONARY BYPASS1,388
KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1,308
DWETubing, Pump, Cardiopulmonary Bypass498
KFMPump, blood, cardiopulmonary bypass, non-roller type372

GMDN & GCC registration

  • GMDN code 35441 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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

Outer Diameter (Millimeter) · 29Length (Meter) · 16Length (Centimeter) · 9Total Volume (Milliliter) · 6Lumen/Inner Diameter (Millimeter) · 3Length (Millimeter) · 3

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

How many cardiopulmonary bypass system blood tubing set products are registered in the US?

15,430 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary bypass system blood tubing set", from 13 companies. The largest labeler is Livanova Usa, Inc. with 35% of records.

Which FDA product codes apply?

DWF (Catheter, cannula and tubing, vascular, cardiopulmonary bypa), DWE (TUBING, PUMP, CARDIOPULMONARY BYPASS), DTZ (OXYGENATOR, CARDIOPULMONARY BYPASS), KFM (PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE)

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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