Identity
- Trade Name
- MPS FDA UDI
- Generic Name
- Cardioplegia solution administration kit FDA UDI
- Device Name
- MPS® Antegrade/Retrograde Y-Set FDA UDI
- Model / Reference
- 5001108 FDA UDI
- Description
- MPS® Antegrade/Retrograde Y-Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634624501188 FDA UDI
- 510(k) Number
- K953838 FDA UDI
- FDA Product Code
- DTR FDA UDI
- GMDN Term
- Cardioplegia solution administration kit 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardioplegia solution administration kit
Mps 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
K953838 also covers:
- Delivery Set 16C w/ AA 35cm Line — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — QUEST MEDICAL INC
- MPS — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quest Medical Inc
Sources (1)
- FDA UDI dbb0dc2e-adf9-4c6b-9132-26cb179504a0 34 fields · synced Jun 8, 2026