Identity
- Trade Name
- RESERVOIR FDA UDI
- Generic Name
- Cardiotomy reservoir FDA UDI
- Model / Reference
- CARD 43 + ADAPTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178250122 FDA UDI
- 510(k) Number
- K061527 FDA UDI
- FDA Product Code
- DTN FDA UDI
- GMDN Term
- Cardiotomy reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiotomy reservoir
Reservoir by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Capiox® Flexible Venous Reservoir — Terumo Cardiovascular Systems Corporation · Class II
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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI c0ac5b4b-547b-488a-b7ad-e12a015a19ae 33 fields · synced Jun 1, 2026