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Device Explorer · FDA GUDID · GMDN 37238

Extracorporeal blood gas/pH monitor

A mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette

US‑registered devices58in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription53%Rx‑only share
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Share of device records

Spectrum Medical Limited3255%
Terumo Cardiovascular Systems Corporation1221%
Medtronic, Inc.814%
Livanova Deutschland Gmbh59%
Maquet Cardiopulmonary Ag12%

Top labelers

CompanyDevicesShare
Spectrum Medical Limited3255%
Terumo Cardiovascular Systems Corporation1221%
Medtronic, Inc.814%
Livanova Deutschland Gmbh59%
Maquet Cardiopulmonary Ag12%

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

Brand names on the register (sample)

QuantumQuantum ®Quantum ® System M ®System M ®System MQuantum ® System M ®MAQUET CARDIOHELPVirtual Kit NumberB-CaptaCDI OneView™ Monitoring SystemCDI® Blood Parameter Monitoring System 550CDI™ Blood Parameter Monitoring System 500BioTrend®Bio Trend®

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

FDA product codes

CodeNameDevices
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass63
DTYSENSOR, BLOOD-GAS, IN-LINE, CARDIOPULMONARY BYPASS9
DRYMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS6
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass3

GMDN & GCC registration

  • GMDN code 37238 · non‑implantable
  • Single‑use 0% · sterile 0% · 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

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

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

How many extracorporeal blood gas/ph monitor products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extracorporeal blood gas/pH monitor", from 5 companies. The largest labeler is Spectrum Medical Limited with 55% of records.

Which FDA product codes apply?

DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), DTY (SENSOR, BLOOD-GAS, IN-LINE, CARDIOPULMONARY BYPASS), DRY (MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS), DTQ (Console, Heart-Lung Machine, 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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