Identity
- Trade Name
- CARESCAPE EUDAMEDCARESCAPE B650 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- CARESCAPE B650 EUDAMEDCARESCAPE B650 MBB313 (ATO MODEL) FDA UDI
- Model / Reference
- MBB313 EUDAMEDFDA UDI2095801-001 EUDAMED
- Description
- CARESCAPE B650 MBB313 (ATO MODEL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682143806 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682143806 EUDAMED
- 510(k) Number
- K191149 FDA UDI
- FDA Product Code
- NHP FDA UDICCL FDA UDIKOI FDA UDIGWQ FDA UDIFLL FDA UDIBZL FDA UDICCK FDA UDIBZQ FDA UDINHO FDA UDIORT FDA UDIDQK FDA UDIDPZ FDA UDIOMC FDA UDIDRT FDA UDIMHX FDA UDIDSI FDA UDIBZK FDA UDIDSK FDA UDICBS FDA UDINHQ FDA UDIDXN FDA UDIOLT FDA UDICBR FDA UDIDQA FDA UDIDXG FDA UDIDPS FDA UDIKRB FDA UDICAP FDA UDIGWJ FDA UDIDSJ FDA UDICBQ FDA UDIMLD FDA UDIOLW FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1500 FDA UDI868.1720 FDA UDI868.2775 FDA UDI882.1400 FDA UDI880.2910 FDA UDI868.1730 FDA UDI868.1400 FDA UDI868.2375 FDA UDI870.1425 FDA UDI870.2710 FDA UDI870.2300 FDA UDI870.1025 FDA UDI868.1850 FDA UDI870.1110 FDA UDI868.1620 FDA UDI870.1130 FDA UDI868.1700 FDA UDI870.2700 FDA UDI870.1435 FDA UDI870.2340 FDA UDI870.1915 FDA UDI868.2600 FDA UDI882.1900 FDA UDI870.1100 FDA UDI
- Market of Registration
- Finland 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
Yes
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
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
Carescape B650 by GE Healthcare Finland Oy — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
Sources (2)
- FDA UDI 6fb25cd7-4c7e-4d30-a39a-f9c4974ab24f 36 fields · synced Oct 6, 2026
- EUDAMED b2102c4f-5344-47f8-99a8-292d415d480e 61 fields · synced Oct 5, 2026