Identity
- Trade Name
- Adult ECC pack 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 Gas Filter FDA UDI
- Model / Reference
- BO-TOP 16402 FDA UDI
- Description
- BO-HMOD 70000-USA Adult Quadrox iD BO-VHK 31000 Venous Res. Pediatric (MACE) BO-RF32 RotaFlow Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701054787 FDA UDI
- Primary DI / UDI-DI
- 00607567203396 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
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 ECC 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 7faaaf5c-1a9f-4d25-a77f-9d15b3d90c27 37 fields · synced Jun 1, 2026