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Calibration gas 1

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
Calibration gas 1 FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Device Name
Gas cylinder 2.5L Gas 1: 5.61 % CO2, 19.76 % O2 FDA UDI
Model / Reference
962-140 FDA UDI
Description
Gas cylinder 2.5L Gas 1: 5.61 % CO2, 19.76 % O2 FDA UDI

Identifiers

Catalog Number
962-140 FDA UDI
Primary DI / UDI-DI
05700699621405 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Calibration gas 1 by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA UDI e379232f-5556-42c1-9fa1-95667aae0ba2 36 fields · synced May 31, 2026