Identity
- Trade Name
- BMU 40 FDA UDI
- Generic Name
- Extracorporeal blood gas/pH monitor FDA UDI
- Device Name
- Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety. FDA UDI
- Model / Reference
- Y-Datacable kit (Lemo auf 2 x DE9f) FDA UDI
- Description
- Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety. FDA UDI
Identifiers
- Catalog Number
- 70104.5532 FDA UDI
- Primary DI / UDI-DI
- 04037691676203 FDA UDI
- 510(k) Number
- K090147 FDA UDI
- FDA Product Code
- DRY FDA UDI
- GMDN Term
- Extracorporeal blood gas/pH monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4330 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bmu 40 by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 daf23ddc-1c80-4643-8ff8-413eb41f98b6 37 fields · synced Jun 8, 2026