Calibration Gas

FDA UDI

Class II (US FDA UDI)

by Radiometer Basel AG

Identity

Trade Name: Calibration Gas FDA UDI
Generic Name: Transcutaneous blood gas monitor sensor FDA UDI
Device Name: CAL gas 6 cyl. FDA UDI
Model / Reference: 0640210 FDA UDI
Description: CAL gas 6 cyl. FDA UDI

Identifiers

Catalog Number: 0640210 FDA UDI
Primary DI / UDI-DI: 15700693095285 FDA UDI
FDA Product Code: KLK FDA UDI
DPZ FDA UDI
DQA FDA UDI
LKD FDA UDI
GMDN Term: Transcutaneous blood gas monitor sensor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2500 FDA UDI
870.2710 FDA UDI
870.2700 FDA UDI
868.2480 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitoring system

Calibration Gas by Radiometer Basel AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Radiometer Basel AG

Sources (1)

FDA UDI a9abdf2e-b901-4f4d-8ada-4b1f3b60db3d 36 fields · synced Jun 1, 2026