Consulting Wallah › Device Explorer › Other devices › Cardiopulmonary bypass system, roller type
Device Explorer · FDA GUDID · GMDN 35099

Cardiopulmonary bypass system, roller type

An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back int

US‑registered devices260in commercial distribution
Companies5labelers on GUDID
Single‑use8%of device records
Sterile7%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Livanova Deutschland Gmbh19173%
Terumo Cardiovascular Systems Corporation2610%
Maquet Cardiopulmonary Ag239%
Avid Medical, Inc.187%
Medtronic, Inc.21%

Top labelers

CompanyDevicesShare
Livanova Deutschland Gmbh19173%
Terumo Cardiovascular Systems Corporation2610%
Maquet Cardiopulmonary Ag239%
Avid Medical, Inc.187%
Medtronic, Inc.21%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MAQUET CARDIOHELPMAQUET CARDIOHELPMAQUET HL-20 SystemHL 20Level Sensor PadsCardiohelpROTAFLOWCapacitive Level SensorDeviceAccessoriesESSENZS5 ConsoleEVOCP5S5 Mast Roller PumpS5 Double Roller Pump 85

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

FDA product codes

CodeNameDevices
DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS181
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass41
OEZCardiovascular procedure kit18
DWAControl, pump speed, cardiopulmonary bypass14
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type9
KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE4

GMDN & GCC registration

  • GMDN code 35099 · non‑implantable
  • Single‑use 8% · sterile 7% · 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

Weight (Kilogram) · 2Total Volume (Liter) · 1

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

How many cardiopulmonary bypass system, roller type products are registered in the US?

260 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiopulmonary bypass system, roller type", from 5 companies. The largest labeler is Livanova Deutschland Gmbh with 73% of records.

Which FDA product codes apply?

DTQ (CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS), DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), OEZ (Cardiovascular procedure kit), DWA (Control, pump speed, cardiopulmonary bypass)

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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