Identity
- Trade Name
- moorVMS-TREND PC Software FDA UDI
- Generic Name
- Tissue saturation oximeter FDA UDI
- Device Name
- moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060484490164 FDA UDI
- FDA Product Code
- MUD FDA UDIGEX FDA UDI
- GMDN Term
- Tissue saturation oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI878.4810 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laser Doppler blood flowmeterTissue saturation oximeter
moorVMS-TREND PC Software by Moor Instruments Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083082 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 |
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Manufacturer
- Manufacturer
- Moor Instruments Limited
Sources (1)
- FDA UDI a0ed9694-6e58-4375-a189-4125ff058975 35 fields · synced Jun 8, 2026