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Bionostic, Inc.

FDA UDI

Class I (US FDA UDI)

by Airgas Therapeutics

Identity

Trade Name
Bionostic, Inc. FDA UDI
Generic Name
Calibration gas/refillable cylinder FDA UDI
Device Name
Description: 6.9% CO2, 17% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
Model / Reference
Calibration Gas FDA UDI
Description
Description: 6.9% CO2, 17% O2, BAL. N2; Cylinder: 300; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI

Identifiers

Catalog Number
Z03NI7643000000 FDA UDI
Primary DI / UDI-DI
00819601025127 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Pressure — 2400 Pound per Square Inch FDA UDI
Total Volume — 8400 Liter FDA UDI

Category: Calibration gas/refillable cylinder

Bionostic, Inc. by Airgas Therapeutics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calibration gas/refillable cylinder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airgas Therapeutics

Sources (1)

  • FDA UDI b297cdcc-5b75-4013-91ec-c52b103fb002 37 fields · synced Jun 8, 2026