Identity
- Trade Name
- Maquet HL-20 System FDA UDI
- Generic Name
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
- Device Name
- Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries. FDA UDI
- Model / Reference
- AEP 20-415 Bubble Level Monitoring Kit FDA UDI
- Description
- Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries. FDA UDI
Identifiers
- Catalog Number
- 70101.0853 FDA UDI
- Primary DI / UDI-DI
- 04037691224510 FDA UDI
- 510(k) Number
- K943803 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system air bubble/fluid level detector 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 28.215 Liter FDA UDIWeight — 4220 Gram FDA UDI
Category: Cardiopulmonary bypass system air bubble/fluid level detector
Maquet HL-20 System 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
K943803 also covers:
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- HL 20 — Maquet Cardiopulmonary AG
- MAQUET HL-20 System — Maquet Cardiopulmonary AG
- MAQUET HL-20 System — Maquet Cardiopulmonary AG
- MAQUET HL-20 System — Maquet Cardiopulmonary AG
- MAQUET HL20 — Maquet Cardiopulmonary AG
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 3167bc60-6953-4899-a3ea-09d9db6f970d 36 fields · synced Jun 8, 2026