Inspira Art100

FDA UDI

Class II (US FDA UDI)

by Inspira Technologies Oxy B.H.N. , Ltd.

Identity

Trade Name: INSPIRA ART100 FDA UDI
Generic Name: Medical device rail FDA UDI
Model / Reference: Packed INSPIRA ART100 Holders FDA UDI

Identifiers

Catalog Number: INS-011101P FDA UDI
Primary DI / UDI-DI: 07290117830086 FDA UDI
510(k) Number: K232788 FDA UDI
FDA Product Code: DWA FDA UDI
GMDN Term: Medical device rail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4380 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical device rail

Inspira Art100 by Inspira Technologies Oxy B.H.N. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K232788 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Inspira Technologies Oxy B.H.N. , Ltd.

Sources (1)

FDA UDI 5716547a-e71f-4758-8ba0-4aa911ad0f90 34 fields · synced Jun 8, 2026