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Device Explorer · FDA GUDID · GMDN 33317

Cardiopulmonary bypass system centrifugal pump drive unit

A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion.

US‑registered devices71in commercial distribution
Companies9labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Medtronic, Inc.3042%
Terumo Cardiovascular Systems Corporation1014%
Apmtd, Inc.1014%
Michigan Critical Care Consultants, Inc.811%
Spectrum Medical Limited46%
Thoratec Switzerland Gmbh46%
Qtrex Quantum Ltd.34%
Asia Pacific Medical Technology Development Company Limited11%

Top labelers

CompanyDevicesShare
Medtronic, Inc.3042%
Terumo Cardiovascular Systems Corporation1014%
Apmtd, Inc.1014%
Michigan Critical Care Consultants, Inc.811%
Spectrum Medical Limited46%
Thoratec Switzerland Gmbh46%
Qtrex Quantum Ltd.34%
Asia Pacific Medical Technology Development Company Limited11%
Xenios Ag11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSPIRA ART100QuantumAnivia SG1000 Pump ConsoleNovalung SystemSarns™ Centrifugal SystemTerumo® Advanced Perfusion System 1NABio-Console®BIOCONSOLE®AFFINITY® NTVitalFlow CaddyVitalFlow Power Cord 12 V DC, 3mVitalFlow Power Cord CEE 7/7, 2.5mVitalFlow Power Cord NEMA-5-15, 3mVitalFlow Flow and Bubble Sensor, 2mVitalFlow Emergency Handcrank

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

FDA product codes

CodeNameDevices
DWAControl, pump speed, cardiopulmonary bypass31
DWAControl, Pump Speed, Cardiopulmonary Bypass24
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use15
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type7
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass7
KRIAccessory Equipment, Cardiopulmonary Bypass2

GMDN & GCC registration

  • GMDN code 33317 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 96% · 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 cardiopulmonary bypass system centrifugal pump drive unit products are registered in the US?

71 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary bypass system centrifugal pump drive unit", from 9 companies. The largest labeler is Medtronic, Inc. with 42% of records.

Which FDA product codes apply?

DWA (Control, pump speed, cardiopulmonary bypass), DWA (Control, Pump Speed, Cardiopulmonary Bypass), QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use), 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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