Identity
- Trade Name
- Rapid Response Universal Pack FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BO-HMOD 70000-USA Adult Quadrox iD, BO-Softshell Venous Reser. 1900ml, Better Bladder 3/8, BO-RF32 RotaFlow, Gas Filter FDA UDI
- Model / Reference
- BO-TOP 13901 FDA UDI
- Description
- BO-HMOD 70000-USA Adult Quadrox iD, BO-Softshell Venous Reser. 1900ml, Better Bladder 3/8, BO-RF32 RotaFlow, Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701054874R01 FDA UDI
- Primary DI / UDI-DI
- 00607567212244 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
Rapid Response Universal 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 54bfa35a-1e4b-4b80-8c71-05c45a4c65c9 37 fields · synced Jun 8, 2026