Identity
- Trade Name
- MPS 3 Console Adapter FDA UDI
- Generic Name
- Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
- Model / Reference
- 5301025 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20634624530250 FDA UDI
- 510(k) Number
- K200438 FDA UDI
- FDA Product Code
- DTR FDA UDIDWC FDA UDI
- GMDN Term
- Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4240 FDA UDI870.4250 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 heat exchanger, reusable
MPS 3 Console Adapter by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system heat exchanger, reusable.
- BIOtherm™ — MEDTRONIC, INC. · Class II
- ECMOtherm- II™ — MEDTRONIC, INC. · Class II
- CSC 14 — SORIN GROUP ITALIA SRL · Class II
- Coronary Sinus Transducer Interface Cable (Retrograde) — QUEST MEDICAL INC · Class II
- MPS Data Output (RS-232) cable — QUEST MEDICAL INC · Class II
- MPS Heater Cooler Hose Kit — QUEST MEDICAL INC · Class II
- MPS Water Hose Connector Kit — QUEST MEDICAL INC · Class II
- MPS Power Cord Keeper — QUEST MEDICAL INC · Class II
Cleared under the same submission
K200438 also covers:
- Aortic Root Transducer Interface Cable (Antegrade) — QUEST MEDICAL INC
- Coronary Sinus Transducer Interface Cable (Retrograde) — QUEST MEDICAL INC
- MPS 3 Additive Cartridge — QUEST MEDICAL INC
- MPS 3 Additive Delivery Line — QUEST MEDICAL INC
- MPS 3 Arrest Agent Delivery Line — QUEST MEDICAL INC
- MPS 3 Arrest Cartridge — QUEST MEDICAL INC
- MPS 3 Articulating Mounting Arm — QUEST MEDICAL INC
- MPS 3 Blood Bypass Tubing — QUEST MEDICAL INC
- MPS 3 Console — QUEST MEDICAL INC
- MPS 3 Console Pole Mount — QUEST MEDICAL INC
- MPS 3 Controller — QUEST MEDICAL INC
- MPS 3 Delivery Set w/183cm (10C) — QUEST MEDICAL 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
- Quest Medical Inc
Sources (1)
- FDA UDI c720a0c2-cbdd-4dbc-8eab-9542a0538653 34 fields · synced Jun 1, 2026