Vyaire

FDA UDI

Class I (US FDA UDI)

by Airgas Usa Llc

Identity

Trade Name: Vyaire FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: Description: 26% O2, Bal. N2; Cylinder: 8D; Valve: CGA 973; For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked; Vyaire Part #: 773868; FDA UDI
Model / Reference: Pulmonary Function Cal Gas FDA UDI
Description: Description: 26% O2, Bal. N2; Cylinder: 8D; Valve: CGA 973; For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked; Vyaire Part #: 773868; FDA UDI

Identifiers

Catalog Number: Z02NI7448DC000 FDA UDI
Primary DI / UDI-DI: 00819601021341 FDA UDI
FDA Product Code: BXK FDA UDI
GMDN Term: Pulmonary function analysis system, adult 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: Total Volume — 88 Liter FDA UDI
Pressure — 2200 Pound per Square Inch FDA UDI

Category: Pulmonary function analysis system, adult

Vyaire by Airgas Usa Llc — 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 Usa Llc

Sources (1)

FDA UDI 71f1a44d-1933-4591-8257-d5c6a02f71fd 37 fields · synced May 30, 2026