Identity
- Trade Name
- INSPIRA ART100 FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Model / Reference
- INSPIRA ART100 Controller FDA UDI
Identifiers
- Catalog Number
- INS-010101 FDA UDI
- Primary DI / UDI-DI
- 07290117830048 FDA UDI
- 510(k) Number
- K232788 FDA UDI
- FDA Product Code
- DWA FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit 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
MR Unsafe FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump drive unit
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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Also classified as Cardiopulmonary bypass system centrifugal pump drive unit.
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- Sarns™ Centrifugal System — Terumo Cardiovascular Systems Corporation · Class II
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Cleared under the same submission
K232788 also covers:
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inspira Technologies Oxy B.H.N. , Ltd.
Sources (1)
- FDA UDI 1ffe8d67-e84e-492d-bf30-f67e282830c7 34 fields · synced May 31, 2026