← Back to catalogue

Calibration Gas 2

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
Calibration Gas 2 FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Device Name
Calibration gas 2, 10bar on-board gas bottle for USA and Canada FDA UDI
Model / Reference
962-175 FDA UDI
Description
Calibration gas 2, 10bar on-board gas bottle for USA and Canada FDA UDI

Identifiers

Catalog Number
962-175 FDA UDI
Primary DI / UDI-DI
05700699621757 FDA UDI
FDA Product Code
CHL FDA UDI
CGL FDA UDI
CGZ FDA UDI
GHS FDA UDI
MQM FDA UDI
CIG FDA UDI
JGS FDA UDI
KQI FDA UDI
CGA FDA UDI
CEM FDA UDI
KHP FDA UDI
JFP 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
862.1225 FDA UDI
862.1170 FDA UDI
864.7425 FDA UDI
862.1113 FDA UDI
862.1110 FDA UDI
862.1665 FDA UDI
864.7455 FDA UDI
862.1345 FDA UDI
862.1600 FDA UDI
862.1450 FDA UDI
862.1145 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 2 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA UDI ad799136-07b6-4d94-a584-2abbdf72af90 36 fields · synced Jun 7, 2026