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Airgas Healthcare

FDA UDI

Class I (US FDA UDI)

by Airgas Usa Llc

Identity

Trade Name
Airgas Healthcare FDA UDI
Generic Name
Multiple blood gas analyte IVD, calibrator FDA UDI
Device Name
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction. FDA UDI
Model / Reference
Device Gas FDA UDI
Description
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction. FDA UDI

Identifiers

Catalog Number
Blood Gas FDA UDI
Primary DI / UDI-DI
00819601020023 FDA UDI
FDA Product Code
BXK FDA UDI
GMDN Term
Multiple blood gas analyte IVD, calibrator 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple blood gas analyte IVD, calibratorBlood gas analyser IVD, point-of-care

Airgas Healthcare by Airgas Usa Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood gas analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airgas Usa Llc

Sources (1)

  • FDA UDI 3ae506a2-344c-4664-8f02-a805bf5b5bc7 36 fields · synced Jun 8, 2026