Identity
- Trade Name
- Custom Tubing Pack with Quadrox iD FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BO-HMOD 70000-USA Adult Quadrox iD, BO-VHK 31000 Venous Res. Pediatric (MACE), BO-RF32 RotaFlow, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter FDA UDI
- Model / Reference
- BO-TOP 26403 FDA UDI
- Description
- BO-HMOD 70000-USA Adult Quadrox iD, BO-VHK 31000 Venous Res. Pediatric (MACE), BO-RF32 RotaFlow, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter FDA UDI
Identifiers
- Catalog Number
- 709000308 FDA UDI
- Primary DI / UDI-DI
- 00607567210585 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
Custom Tubing Pack with Quadrox iD 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 ebb76832-4c24-4087-b09d-e82e2b03f573 37 fields · synced May 30, 2026