Identity
- Trade Name
- Adult CPB Pack with VKMO 71000 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, Gas Filter FDA UDI
- Model / Reference
- BO-TOP 19000 FDA UDI
- Description
- HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701051874 FDA UDI
- Primary DI / UDI-DI
- 00607567200418 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
No
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 Pack with VKMO 71000 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA UDI 9779416f-4826-4e8e-b0ac-3cb4aaaf5d1a 37 fields · synced Jun 8, 2026