Identity
- Trade Name
- Terumo® Advanced Perfusion System 1 FDA UDI
- Generic Name
- Cardiopulmonary bypass system roller pump FDA UDI
- Device Name
- The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universl tube clamp mechanism accommodates a variety of tubing sizes, including dual tube sets. FDA UDI
- Model / Reference
- 816570 FDA UDI
- Description
- The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universl tube clamp mechanism accommodates a variety of tubing sizes, including dual tube sets. FDA UDI
Identifiers
- Catalog Number
- 816570 FDA UDI
- Primary DI / UDI-DI
- 00886799001363 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system roller pump 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 roller pump
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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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 cce626ed-e92d-409b-843b-37451fa526e7 34 fields · synced Jun 9, 2026