Identity
- Trade Name
- E/P Pack FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Model / Reference
- C5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04033817901426 FDA UDI
- 510(k) Number
- K093882 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
E/P Pack 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
K093882 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 |
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Manufacturer
- Manufacturer
- LivaNova Deutschland GmbH
Sources (1)
- FDA UDI d21dafed-7b98-4831-99f7-8092fa0bee00 33 fields · synced May 31, 2026