Identity
- Trade Name
- MPS 3 Delivery Set w/183cm (10C) FDA UDI
- Generic Name
- Cardioplegia solution administration kit FDA UDI
- Model / Reference
- 5003100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634624500310 FDA UDI
- 510(k) Number
- K200438 FDA UDI
- FDA Product Code
- DWC FDA UDIDTR FDA UDI
- GMDN Term
- Cardioplegia solution administration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4250 FDA UDI870.4240 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardioplegia solution administration kit
MPS 3 Delivery Set w/183cm (10C) by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardioplegia solution administration kit.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
- MyOtherm XP® — MEDTRONIC, INC. · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · 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 Adapter — QUEST MEDICAL INC
- MPS 3 Console Pole Mount — QUEST MEDICAL INC
- MPS 3 Controller — 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 77f98a84-91b6-431f-9393-e5b09cd7cf80 34 fields · synced May 30, 2026