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Device Explorer · FDA GUDID · GMDN 36552

Patient monitoring system module, carbon dioxide

A small unit dedicated to the measurement of carbon dioxide (CO2) content of expired gas obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as p

US‑registered devices80in commercial distribution
Companies14labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Respironics Novametrix, Llc2228%
Masimo Corporation2025%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2025%
Draeger Medical Systems, Inc.56%
Drägerwerk Ag & Co. Kgaa22%
Philips Medizin Systeme Böblingen Gmbh22%
Spacelabs Healthcare (Washington), Inc22%
Edan Instruments, Inc.11%

Top labelers

CompanyDevicesShare
Respironics Novametrix, Llc2228%
Masimo Corporation2025%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2025%
Draeger Medical Systems, Inc.56%
Drägerwerk Ag & Co. Kgaa22%
Philips Medizin Systeme Böblingen Gmbh22%
Spacelabs Healthcare (Washington), Inc22%
Edan Instruments, Inc.11%
Shanghai Draeger Medical Instrument Co.,Ltd.11%
Ge Healthcare Finland Oy11%
Zoll Medical Corporation11%
Athena Gtx, Inc.11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ISA™ CO2IRMA™ CO2IRMA™ CO2 RootRadius PCG™ KitRadius PCG™EMMA™EMMA™ KitCAPNOSTAT CO2 mod upgrd kitORIDION CO2 mod upgrd kit,intlCAPNOSTAT CO2 upgrade packageM02B CO2 mod upgrd pkg,neonateM02B CO2 module upgrade package(Adult /PIBP_CO_MicrostreamCO2 module(FDA/FJ/PK.)IBP_CO_SidestreamCO2 module(FDA/FJ/PK.)Sidestream CO2 module(FDA/FJ/PK.)Sidestream CO2 module(FDA/PK.)

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

FDA product codes

CodeNameDevices
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase31
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE28
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR22
CBKVentilator, Continuous, Facility Use2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio1
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ1

GMDN & GCC registration

  • GMDN code 36552 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 91% · 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 patient monitoring system module, carbon dioxide products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient monitoring system module, carbon dioxide", from 14 companies. The largest labeler is Respironics Novametrix, Llc with 28% of records.

Which FDA product codes apply?

CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), CBK (Ventilator, Continuous, Facility Use)

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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