Identity
- Trade Name
- CARESCAPE FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- Monitor B650 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682105200 FDA UDI
- 510(k) Number
- K131223 FDA UDI
- FDA Product Code
- DQA FDA UDIOLT FDA UDIBZQ FDA UDICBQ FDA UDIDSJ FDA UDIDSI FDA UDIDPZ FDA UDIDSK FDA UDIORT FDA UDICCK FDA UDIMLD FDA UDIGWQ FDA UDIKRB FDA UDIBZL FDA UDIMHX FDA UDIOMC FDA UDIKOI FDA UDICCL FDA UDIDRT FDA UDIDQK FDA UDINHO FDA UDIFLL FDA UDIGWJ FDA UDIDXG FDA UDIBZK FDA UDIOLW FDA UDINHP FDA UDIDPS FDA UDIDXN FDA UDICBS FDA UDICBR FDA UDICAP FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI882.1400 FDA UDI868.2375 FDA UDI868.1500 FDA UDI870.1100 FDA UDI870.1025 FDA UDI870.2710 FDA UDI870.1110 FDA UDI868.1400 FDA UDI870.1915 FDA UDI868.1730 FDA UDI868.2775 FDA UDI868.1720 FDA UDI870.2300 FDA UDI870.1425 FDA UDI880.2910 FDA UDI882.1900 FDA UDI870.1435 FDA UDI868.1850 FDA UDI870.2340 FDA UDI870.1130 FDA UDI868.1620 FDA UDI868.1700 FDA UDI868.2600 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
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
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 by GE Healthcare Finland Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131223 also covers:
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
- GE Healthcare Finland Oy
Sources (1)
- FDA UDI b7dfbdd6-f4fa-4ffd-8c31-78c80305246f 35 fields · synced Jun 8, 2026