Identity
- Trade Name
- Adult CPB FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- HMO 71000 (BO coated) Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir BO-RF32 RotaFlow SAT/CRIT conn 1/2" Prebypass filter w/o Vent Porous Media 3/8x1/2 Gas Filter FDA UDI
- Model / Reference
- BO-TOP 15502 FDA UDI
- Description
- HMO 71000 (BO coated) Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir BO-RF32 RotaFlow SAT/CRIT conn 1/2" Prebypass filter w/o Vent Porous Media 3/8x1/2 Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701065193 FDA UDI
- Primary DI / UDI-DI
- 00607567205611 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Adult CPB by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Datascope Corp.
Sources (1)
- FDA UDI 4b7ee2f4-af3d-41aa-b1a4-fd1bd1ccb126 37 fields · synced Jun 8, 2026