Identity
- Trade Name
- CARESCAPE Canvas Smart Display FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- CARESCAPE Canvas Smart Display FDA UDI
- Model / Reference
- 5897060 FDA UDI
- Description
- CARESCAPE Canvas Smart Display FDA UDI
Identifiers
- Catalog Number
- 5897060 FDA UDI
- Primary DI / UDI-DI
- 00195278522313 FDA UDI
- 510(k) Number
- K223531 FDA UDI
- FDA Product Code
- ORT FDA UDIDXG FDA UDIDXN FDA UDIDSJ FDA UDIDSI FDA UDIDQA FDA UDICCK FDA UDINHQ FDA UDIBZL FDA UDINHO FDA UDIBSK FDA UDIGWQ FDA UDIBZQ FDA UDIDPS FDA UDIOMC FDA UDIOLW FDA UDIKOI FDA UDIMDL FDA UDIOLT FDA UDIDPZ FDA UDIDRT FDA UDIBZK FDA UDICAP FDA UDIKRB FDA UDICBS FDA UDICBQ FDA UDIDQK FDA UDIMUD FDA UDINHP FDA UDICCL FDA UDIMHX FDA UDIFLL FDA UDICBR FDA UDIQEM FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.1435 FDA UDI870.1130 FDA UDI870.1100 FDA UDI870.1025 FDA UDI870.2700 FDA UDI868.1400 FDA UDI868.1500 FDA UDI868.1730 FDA UDI868.5750 FDA UDI868.2375 FDA UDI870.2340 FDA UDI868.2775 FDA UDI872.4760 FDA UDI870.2710 FDA UDI870.2300 FDA UDI868.1850 FDA UDI868.2600 FDA UDI870.1915 FDA UDI868.1620 FDA UDI870.1425 FDA UDI868.1720 FDA UDI880.2910 FDA UDI868.1700 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 Canvas Smart Display by GE Healthcare Finland Oy — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 07f49361-4b5f-4a55-95d4-fdd62c0f47cb 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026