Identity
- Trade Name
- Open heart pack no plegiox FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BEQ-HMOD 71000 BO-VHK 71000 Blood Transfer Bag 1000 BEQ- RF Rotaflow BC 60plus cdi SAT 1/2" prebypass filter gas filter FDA UDI
- Model / Reference
- BEQ-TOP 40010 FDA UDI
- Description
- BEQ-HMOD 71000 BO-VHK 71000 Blood Transfer Bag 1000 BEQ- RF Rotaflow BC 60plus cdi SAT 1/2" prebypass filter gas filter FDA UDI
Identifiers
- Catalog Number
- 701067364 FDA UDI
- Primary DI / UDI-DI
- 00607567206304 FDA UDI
- FDA Product Code
- DWE FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4390 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
Open heart pack no plegiox 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 bb4adcea-b29a-4e49-a9c5-06cdb49ea22e 37 fields · synced May 30, 2026