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Device Explorer · FDA GUDID · GMDN 65332

Calibration gas/refillable cylinder

A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, refillable, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the prop

US‑registered devices90in commercial distribution
Companies4labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Airgas Usa Llc5157%
Airgas Therapeutics, Llc3539%
Global Calibration Gases Llc22%
Maine Oxy22%

Top labelers

CompanyDevicesShare
Airgas Usa Llc5157%
Airgas Therapeutics, Llc3539%
Global Calibration Gases Llc22%
Maine Oxy22%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Calibration GasBlood Gas MixtureLung Diffusion MixtureOridionMasimoSIEMENS HEALTHCAREScott Medical ProductsBionostic, Inc.Masimo Corp.GE HealthcareInvivo CorporationSiemensAirgas USA LLC

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)90

GMDN & GCC registration

  • GMDN code 65332 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 2% · 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

Total Volume (Liter) · 86Pressure (Pound per Square Inch) · 85

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

How many calibration gas/refillable cylinder products are registered in the US?

90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Calibration gas/refillable cylinder", from 4 companies. The largest labeler is Airgas Usa Llc with 57% of records.

Which FDA product codes apply?

BXK (Gas, Calibration (Specified Concentration))

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.

How do I get quotes?

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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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