Siemens

FDA UDI

Class I (US FDA UDI)

by Airgas Usa Llc

Identity

Trade Name: Siemens FDA UDI
Generic Name: Multiple blood gas analyte IVD, calibrator FDA UDI
Device Name: Description: 17% N2O, 18% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
Model / Reference: Calibration gas FDA UDI
Description: Description: 17% N2O, 18% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI

Identifiers

Catalog Number: Z03NI65M3000001 FDA UDI
Primary DI / UDI-DI: 00819601022027 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

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 — 2400 Pound per Square Inch FDA UDI
Total Volume — 9484 Liter FDA UDI

Category: Multiple blood gas analyte IVD, calibrator

Siemens 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 a0aa93a5-c257-44e3-bc19-ac557648298d 37 fields · synced May 31, 2026