Identity
- Trade Name
- MAQUET CARDIOHELP FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Device Name
- The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-Hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours). FDA UDI
- Model / Reference
- CARDIOHELP-i FDA UDI
- Description
- The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-Hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours). FDA UDI
Identifiers
- Catalog Number
- 70107.2780 FDA UDI
- Primary DI / UDI-DI
- 04058863074863 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
Yes
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
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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 |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI aad2ac39-8aa0-4bc5-abfc-c48725cdc659 36 fields · synced May 30, 2026