Identity
- Trade Name
- Terumo® Advanced Perfusion System 1 FDA UDI
- Generic Name
- Cardiopulmonary bypass system gas control unit FDA UDI
- Device Name
- The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM. FDA UDI
- Model / Reference
- 801188 FDA UDI
- Description
- The electronic gas blender is an optional module that integrates into the APS1 chassis. It accepts inputs of medical grade oxygen and air, or oxygen and 95/5 (a blend of 95% oxygen and 5% carbon dioxide), and allows the ser to control and regulate the gas output to an oxygenator. A built-in oxygen analyzer measures the oxygen content of the blended gas and provides the information to the system for display on the CCM. FDA UDI
Identifiers
- Catalog Number
- 801188 FDA UDI
- Primary DI / UDI-DI
- 00886799000588 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system gas control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system gas control unit
Terumo® Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system gas control unit.
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI e7ea585b-a06e-4f8b-9420-6dded2d2ea17 34 fields · synced Jun 9, 2026