Identity
- Trade Name
- S5 Mast Roller Pump FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Model / Reference
- Control Panel for 1 MRP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04033817900818 FDA UDI
- 510(k) Number
- K103762 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system, roller type 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, roller type
S5 Mast Roller Pump by LivaNova Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system, roller type.
- HL 20 — Maquet Cardiopulmonary AG · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- ROTAFLOW — Maquet Cardiopulmonary AG · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- MAQUET HL-20 System — Maquet Cardiopulmonary AG · Class II
- MAQUET HL-20 System — Maquet Cardiopulmonary AG · Class II
Cleared under the same submission
K103762 also covers:
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
- LivaNova Deutschland GmbH
Sources (1)
- FDA UDI 8ed208c1-1fa3-40d6-84c5-94737aee12a6 33 fields · synced Jun 8, 2026