Identity
- Trade Name
- FILAC FDA UDI
- Generic Name
- Multiple physiological parameter spot-check system, clinical FDA UDI
- Model / Reference
- 52-0009-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840935106579 FDA UDI
- 510(k) Number
- K160439 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Multiple physiological parameter spot-check system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple physiological parameter spot-check system, clinical
Filac by Suntech Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160439 also covers:
- Adview II — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
- AdviewII™ — American Diagnostic Corporation
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
- Suntech Medical, Inc.
Sources (1)
- FDA UDI 6aa0ce86-d13a-4f91-a8df-417da2514874 34 fields · synced Jun 8, 2026