Consulting Wallah › Device Explorer › IVD & laboratory › Multiple blood gas analyte IVD, calibrator
Device Explorer · FDA GUDID · GMDN 35933

Multiple blood gas analyte IVD, calibrator

A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

US‑registered devices135in commercial distribution
Companies16labelers on GUDID
Single‑use21%of device records
Sterile0%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Airgas Usa Llc9873%
Siemens Healthcare Diagnostics Inc.118%
Radiometer Medical Aps75%
Matheson Tri-Gas, Inc.21%
Oxarc, Inc.21%
Red Ball Oxygen Co., Inc.21%
Industrial Source21%
Middlesex Gases & Technologies, Inc.21%

Top labelers

CompanyDevicesShare
Airgas Usa Llc9873%
Siemens Healthcare Diagnostics Inc.118%
Radiometer Medical Aps75%
Matheson Tri-Gas, Inc.21%
Oxarc, Inc.21%
Red Ball Oxygen Co., Inc.21%
Industrial Source21%
Middlesex Gases & Technologies, Inc.21%
Linde Gas & Equipment Inc.21%
Global Calibration Gases Llc11%
Norco, Inc.11%
A-Ox Welding Supply, Co., Inc.11%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Crea Calibration Solution 1Crea Calibration Solution 2Calibration Solution 2Calibration Solution 1Calibration SolutionCalibration Gas MixtureBlood Gas MixtureCalibration GasDevice Calibration MixtureClinical Blood Gas MixtureCalibration MixtureNorLabLungFit® PH Calibration KitClinical Blood GasClinical Blood Gas MixturesMediPure Calibration Gas Mixtures

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

FDA product codes

CodeNameDevices
BXKGas, Calibration (Specified Concentration)117
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH17
JFPELECTRODE, ION SPECIFIC, CALCIUM13
CGZELECTRODE, ION-SPECIFIC, CHLORIDE13
CEMELECTRODE, ION SPECIFIC, POTASSIUM13
JGSELECTRODE, ION SPECIFIC, SODIUM13

GMDN & GCC registration

  • GMDN code 35933 · non‑implantable
  • Single‑use 21% · sterile 0% · Rx‑only 20% · 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

Pressure (Pound per Square Inch) · 97Total Volume (Liter) · 96

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How many multiple blood gas analyte ivd, calibrator products are registered in the US?

135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple blood gas analyte IVD, calibrator", from 16 companies. The largest labeler is Airgas Usa Llc with 73% of records.

Which FDA product codes apply?

BXK (Gas, Calibration (Specified Concentration)), CHL (ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH), JFP (ELECTRODE, ION SPECIFIC, CALCIUM), CGZ (ELECTRODE, ION-SPECIFIC, CHLORIDE)

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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