Identity
- Trade Name
- MPS Retrograde Cable FDA UDI
- Generic Name
- Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
- Model / Reference
- 511600R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20634624511600 FDA UDI
- 510(k) Number
- K041979 FDA UDI
- FDA Product Code
- DTR FDA UDI
- GMDN Term
- Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4240 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system heat exchanger, reusable
MPS Retrograde Cable 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
K041979 also covers:
- MPS 2 — QUEST MEDICAL INC
- MPS Antegrade Cable — QUEST MEDICAL INC
- MPS Data Output (RS-232) cable — QUEST MEDICAL INC
- MPS Power Cord Keeper — QUEST MEDICAL INC
- MPS Power Cord, North America — QUEST MEDICAL INC
- MPS Power Cord, North America, Refurbished — QUEST MEDICAL INC
- MPS Transducer Holder — QUEST MEDICAL INC
- MPS2 Console — QUEST MEDICAL INC
- MPS2 Console — QUEST MEDICAL INC
- MPS2 console — 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 5ad1d543-e0b1-4a9e-a0a3-21bc917b868f 33 fields · synced Jun 8, 2026