Identity
- Trade Name
- BS 3/8”x 3/32” L1.7 EUDAMEDMAQUET CARDIOHELP FDA UDI
- Generic Name
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
- Device Name
- BS 3/8”x 3/32” L1.7 EUDAMEDMAQUET CARDIOHELP Bubble Sensor BS 3/8x3/32 L1.7 FDA UDI
- Model / Reference
- 701055720 EUDAMEDBS 3/8x3/32 L1.7 FDA UDI
- Description
- MAQUET CARDIOHELP Bubble Sensor BS 3/8x3/32 L1.7 FDA UDI
Identifiers
- Catalog Number
- 70105.5720 FDA UDI
- Primary DI / UDI-DI
- 04037691816432 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04037691816432 EUDAMED
- 510(k) Number
- K133598 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- EMDN Code
- C030199 EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4220 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
BS 3/8”x 3/32” L1.7 by Maquet Cardiopulmonary GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04037691816432 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (2)
- EUDAMED 5a8fe34d-3655-438a-b3ae-08a26e0bee90 61 fields · synced Jun 20, 2026
- FDA UDI 7fdf76be-500b-4746-9910-f552fa70eeb1 35 fields · synced May 30, 2026