Identity
- Trade Name
- Skyline 55 wireless FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Central Nursing Station or Central Monitoring System FDA UDI
- Model / Reference
- F3-87-390-0074-49 FDA UDI
- Description
- Central Nursing Station or Central Monitoring System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18904269451520 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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: Centralized patient monitor
Skyline 55 wireless by Skanray Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Skanray Technologies
Sources (1)
- FDA UDI deba14dc-c84c-4de4-a8fe-eec3672d7e19 33 fields · synced Jun 8, 2026