Identity
- Trade Name
- CAPIOX® VENOUS RESERVOIR FDA UDI
- Generic Name
- Cardiotomy reservoir FDA UDI
- Model / Reference
- CX*VRA0701T2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987350706591 FDA UDI
- FDA Product Code
- DTM FDA UDI
- GMDN Term
- Cardiotomy reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4260 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
Capiox® Venous Reservoir by Terumo Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiotomy reservoir.
- RESERVOIR — SORIN GROUP ITALIA SRL · Class II
- BMR — SORIN GROUP ITALIA SRL · Class II
- Affinity — MEDTRONIC, INC. · Class II
- Intersept™ — MEDTRONIC, INC. · Class II
- RESERVOIR — SORIN GROUP ITALIA SRL · Class II
- RESERVOIR — SORIN GROUP ITALIA SRL · Class II
- Capiox® Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- Quantum Perfusion Hybrid System — SPECTRUM MEDICAL LIMITED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terumo Corp.
Sources (1)
- FDA UDI 07b5e79b-df2d-4925-9140-9d7a04455382 34 fields · synced May 30, 2026