Identity
- Trade Name
- Open Heart Pack FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BE-HMO 71000 VHK 71000 BEQ-RF32 BC 60 Plus BMU CEll Prebypass Filter Bacteria Filter Gas Fileter FDA UDI
- Model / Reference
- BEQ-TOP 29400 FDA UDI
- Description
- BE-HMO 71000 VHK 71000 BEQ-RF32 BC 60 Plus BMU CEll Prebypass Filter Bacteria Filter Gas Fileter FDA UDI
Identifiers
- Catalog Number
- 701052489 FDA UDI
- Primary DI / UDI-DI
- 00607567201194 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 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 7b1f5e3a-a77e-488f-b5d6-2559f0dd7abc 37 fields · synced May 30, 2026