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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
Centrifugal circulatory assist pump, manual FDA UDI
Model / Reference
INSPIRA ART100 Emergency Manual Pump Drive FDA UDI

Identifiers

Catalog Number
INS-010301 FDA UDI
Primary DI / UDI-DI
07290117830062 FDA UDI
510(k) Number
K232788 FDA UDI
FDA Product Code
DWA FDA UDI
GMDN Term
Centrifugal circulatory assist pump, manual 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Centrifugal circulatory assist pump, manual

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

Similar devices

Also classified as Centrifugal circulatory assist pump, manual.

Cleared under the same submission

K232788 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 137bb6b5-dc1f-4f8a-bb41-0e2722bf1cb2 34 fields · synced May 30, 2026