Identity
- Trade Name
- MAQUET HL20 FDA UDI
- Generic Name
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
- Device Name
- BSC 20-500 Bubble Sensor FDA UDI
- Model / Reference
- BSC 20-500 FDA UDI
- Description
- BSC 20-500 Bubble Sensor FDA UDI
Identifiers
- Catalog Number
- 70101.0858 FDA UDI
- Primary DI / UDI-DI
- 04037691024110 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
Category: Cardiopulmonary bypass system air bubble/fluid level detector
Maquet Hl20 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 HL-20 System — 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 16f39190-e56d-41cd-a73f-446fe8a747e2 35 fields · synced Jun 6, 2026