← Back to catalogue

Gas mixture cylinder

FDA UDI

Class I (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
Gas mixture cylinder FDA UDI
Generic Name
Calibration gas/non-refillable cylinder FDA UDI
Device Name
Gas mixture cylinder 1 litre 5% CO2, 20.9% O2, balance: N2 FDA UDI
Model / Reference
962-106 FDA UDI
Description
Gas mixture cylinder 1 litre 5% CO2, 20.9% O2, balance: N2 FDA UDI

Identifiers

Catalog Number
962-106 FDA UDI
Primary DI / UDI-DI
05700699621061 FDA UDI
FDA Product Code
BXK FDA UDI
GMDN Term
Calibration gas/non-refillable cylinder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.6400 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: Calibration gas/non-refillable cylinder

Gas mixture cylinder by Radiometer Medical ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calibration gas/non-refillable cylinder.

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 49361fa7-7937-4bae-a3d6-721c55658b52 36 fields · synced Jun 1, 2026