Identity
- Trade Name
- MAQUET CARDIOHELP FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Device Name
- CARDIOHELP Emergency Drive FDA UDI
- Model / Reference
- CARDIOHELP Emergency Drive (w/o holder) FDA UDI
- Description
- CARDIOHELP Emergency Drive FDA UDI
Identifiers
- Catalog Number
- 70107.1881 FDA UDI
- Primary DI / UDI-DI
- 04058863112176 FDA UDI
- 510(k) Number
- K133598 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
Maquet Cardiohelp by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system, roller type.
- Variolock — LivaNova Deutschland GmbH · Class II
- Venous Line Clamp — LivaNova Deutschland GmbH · Class II
- SCP — LivaNova Deutschland GmbH · Class II
- Accessories — LivaNova Deutschland GmbH · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- S5 Roller Pump 150 — LivaNova Deutschland GmbH · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- S5 Shelf without AC Outlet Strip — LivaNova Deutschland GmbH · Class II
Cleared under the same submission
K133598 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
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI fa63ea37-066f-45a1-8573-15e105929714 36 fields · synced May 31, 2026