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Device Explorer · FDA GUDID · GMDN 65331

Calibration gas/non-refillable cylinder

A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, 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 proper gas type,

US‑registered devices169in commercial distribution
Companies6labelers on GUDID
Single‑use8%of device records
Sterile1%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Airgas Usa Llc9254%
Airgas Therapeutics, Llc6036%
Medsource International Llc117%
Quintron Instrument Company, Inc.32%
Radiometer Medical Aps21%
Angioadvancements, Llc11%

Top labelers

CompanyDevicesShare
Airgas Usa Llc9254%
Airgas Therapeutics, Llc6036%
Medsource International Llc117%
Quintron Instrument Company, Inc.32%
Radiometer Medical Aps21%
Angioadvancements, Llc11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Calibration GasGas mixture cylinderMedco2go Carbon Dioxide CartridgeQuinGasQuinGas Regulator & Pressure GaugeMedSource O2 CylinderAirgas TherapeuticsRespitecScott Medical ProductsMasimoGANSHORN INDUSTRIESDIAMOND DIAGNOSTICSJaeger MedicalCGAZ TECHNOLOGY FZGE HealthcareDatalink S&T

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)155
CANRegulator, Pressure, Gas Cylinder12
LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS2
LPPMonitor, oxygen, cutaneous, for uses other than for infant n2
KLKMonitor, oxygen, cutaneous, for infant not under gas anesthe2
DQAOximeter2

GMDN & GCC registration

  • GMDN code 65331 · non‑implantable
  • Single‑use 8% · sterile 1% · Rx‑only 8% · 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) · 149Total Volume (Liter) · 149Weight (Pound) · 1

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

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

169 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Calibration gas/non-refillable cylinder", from 6 companies. The largest labeler is Airgas Usa Llc with 54% of records.

Which FDA product codes apply?

BXK (Gas, Calibration (Specified Concentration)), CAN (Regulator, Pressure, Gas Cylinder), LKD (MONITOR, CARBON-DIOXIDE, CUTANEOUS), LPP (Monitor, oxygen, cutaneous, for uses other than for infant n)

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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