Identity
- Trade Name
- TCH 3/8 Quadrox iD Pack FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000ml - 2 spike ports, BEQ-RF32 Rotaflow, CDI Sat Cell 3/8" Systems 100, Blood Microfilter Systems SQ 40 S, prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter FDA UDI
- Model / Reference
- BEQ-TOP 5900 FDA UDI
- Description
- BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000ml - 2 spike ports, BEQ-RF32 Rotaflow, CDI Sat Cell 3/8" Systems 100, Blood Microfilter Systems SQ 40 S, prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701050228R01 FDA UDI
- Primary DI / UDI-DI
- 00607567212275 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
- 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
Category: Cardiopulmonary bypass system blood tubing set
TCH 3/8 Quadrox iD Pack by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary bypass system blood tubing set.
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- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
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 5411e5db-bff0-4a8b-addc-2dac293877e6 36 fields · synced Jun 1, 2026