Airgas USA LLC

FDA UDI

Class I (US FDA UDI)

by Airgas Therapeutics

Identity

Trade Name: Airgas USA LLC FDA UDI
Generic Name: Calibration gas/refillable cylinder FDA UDI
Device Name: Description: 0.6% C2H2, 9% He, 21% O2, Bal. N2; Cylinder: 200; Valve: CGA 500; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions. FDA UDI
Model / Reference: Pulmonary Function Gas FDA UDI
Description: Description: 0.6% C2H2, 9% He, 21% O2, Bal. N2; Cylinder: 200; Valve: CGA 500; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions. FDA UDI

Identifiers

Catalog Number: Z04NI6952000068 FDA UDI
Primary DI / UDI-DI: 00819601020139 FDA UDI
FDA Product Code: BXK FDA UDI
GMDN Term: Calibration gas/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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Pressure — 2000 Pound per Square Inch FDA UDI
Total Volume — 5947 Liter FDA UDI

Category: Calibration gas/refillable cylinder

Airgas USA LLC by Airgas Therapeutics — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Airgas Therapeutics

Sources (1)

FDA UDI 11ab0fee-e418-40d3-858e-52bbe4a1e478 37 fields · synced May 30, 2026