Diamond Diagnostics

FDA UDI

Class I (US FDA UDI)

by Airgas Therapeutics

Identity

Trade Name: DIAMOND DIAGNOSTICS FDA UDI
Generic Name: Calibration gas/non-refillable cylinder FDA UDI
Device Name: Description: 10% CO2, BAL. N2; Cylinder: QD; Valve: CGA 600; For calibration of medical analyzers in accordance with manufacturer's instructions.; Contained in Kit: SM-105070D (00819601025783) FDA UDI
Model / Reference: Calibration Gas FDA UDI
Description: Description: 10% CO2, BAL. N2; Cylinder: QD; Valve: CGA 600; For calibration of medical analyzers in accordance with manufacturer's instructions.; Contained in Kit: SM-105070D (00819601025783) FDA UDI

Identifiers

Catalog Number: Z02NI908QDC000 FDA UDI
Primary DI / UDI-DI: 00819601025769 FDA UDI
FDA Product Code: BXK FDA UDI
GMDN Term: Calibration gas/non-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: Total Volume — 22 Liter FDA UDI
Pressure — 323 Pound per Square Inch FDA UDI

Category: Calibration gas/non-refillable cylinder

Diamond Diagnostics 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 ffcb8293-4e2f-4c72-83ea-79b984d185d7 37 fields · synced May 30, 2026