Identity
- Trade Name
- Lg Patient Tubing Pack NO OXY FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- Softshell Venous Reser 1900 ml Blood Transfer Bag 1000 ml Better Bladder 3/8 BEQ RF32 Rotaflow Prebypass filter w/o Vent Porous Media 3/8 x 3/8 Gas Filter FDA UDI
- Model / Reference
- BEQ-T 9405 FDA UDI
- Description
- Softshell Venous Reser 1900 ml Blood Transfer Bag 1000 ml Better Bladder 3/8 BEQ RF32 Rotaflow Prebypass filter w/o Vent Porous Media 3/8 x 3/8 Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701066366 FDA UDI
- Primary DI / UDI-DI
- 00607567205826 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
Lg Patient Tubing Pack NO OXY 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 169d93e1-0fcb-4790-853f-4da573398527 37 fields · synced May 30, 2026