Identity
- Trade Name
- Adult CPS Quadrox iD with Rotaflow wo Quadrox FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- Softshell Venous Reser. 800ml BEQ-RF32 RotaFlow Blood Microfilter System SQ 40 S Gas Filter FDA UDI
- Model / Reference
- BEQ-T 38300 FDA UDI
- Description
- Softshell Venous Reser. 800ml BEQ-RF32 RotaFlow Blood Microfilter System SQ 40 S Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701066728 FDA UDI
- Primary DI / UDI-DI
- 00607567208667 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
Adult CPS Quadrox iD with Rotaflow wo Quadrox 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 8d8d833e-f28a-4644-9c26-3d95dd609e50 37 fields · synced Jun 8, 2026