Identity
- Trade Name
- STAR 65 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Multi-Parameter Patient Monitoring System FDA UDI
- Model / Reference
- F3-86-390-1000-21 FDA UDI
- Description
- Multi-Parameter Patient Monitoring System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18904269452886 FDA UDI
- FDA Product Code
- KRB FDA UDICBR FDA UDINHQ FDA UDICBS FDA UDIMNR FDA UDICCL FDA UDINHP FDA UDIMWI FDA UDIDRT FDA UDIDSJ FDA UDIDXN FDA UDIDXG FDA UDIDSF FDA UDIDRS FDA UDICCK FDA UDIFLL FDA UDINHO FDA UDICBQ FDA UDIDQA FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1915 FDA UDI868.1700 FDA UDI868.1500 FDA UDI868.1620 FDA UDI868.2375 FDA UDI868.1720 FDA UDI870.2300 FDA UDI870.1100 FDA UDI870.1130 FDA UDI870.1435 FDA UDI870.2810 FDA UDI870.2850 FDA UDI868.1400 FDA UDI880.2910 FDA UDI870.2700 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
Star 65 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 1caeba52-bb33-40c4-9991-168a6d80143a 33 fields · synced Jun 8, 2026