Identity
- Trade Name
- Terumo® Advanced Perfusion System 1 FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Device Name
- The centrifugal control unit provides the local display and control mechanism for the centrifugal pump and serves as the interface between the centrifugal motor and the rest of the heart-lung system. FDA UDI
- Model / Reference
- 801046 FDA UDI
- Description
- The centrifugal control unit provides the local display and control mechanism for the centrifugal pump and serves as the interface between the centrifugal motor and the rest of the heart-lung system. FDA UDI
Identifiers
- Catalog Number
- 801046 FDA UDI
- Primary DI / UDI-DI
- 00886799000557 FDA UDI
- 510(k) Number
- K151349 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4220 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: Cardiopulmonary bypass system centrifugal pump drive unit
Terumo® Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — 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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- Anivia SG1000 Pump Console — Apmtd, Inc. · Class II
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
- Bio-Console® — MEDTRONIC, INC. · Class II
- METAL LOCKING FEATURE FOR CENTRIMAG MOTOR — Thoratec Switzerland GmbH · Class II
Cleared under the same submission
K151349 also covers:
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation
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
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI 3a23a670-6bb5-4432-8f0b-46acff9e2cd1 35 fields · synced Jun 9, 2026