moorVMS-TREND PC Software

GUDID 15060484490164

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.

MOOR INSTRUMENTS LIMITED

Tissue saturation oximeter

• Primary Device ID: 15060484490164
• NIH Device Record Key: a0ed9694-6e58-4375-a189-4125ff058975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: moorVMS-TREND PC Software
• Version Model Number: 1
• Company DUNS: 398037580
• Company Name: MOOR INSTRUMENTS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +44129735715
• Email: service@moor.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060484490164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083082

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-31

Devices Manufactured by MOOR INSTRUMENTS LIMITED

• 15060484490164 - moorVMS-TREND PC Software: 2019-11-08moorVMS-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.
• 15060484490164 - moorVMS-TREND PC Software: 2019-11-08 moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend
• 15060484490133 - Moor Instruments Ltd: 2019-01-14 Non-sterile Laser Doppler Probes
• 15060484490140 - Moor Instruments Ltd: 2019-01-14 Non-sterile Oxygenation, and Laser Doppler combined Probes
• 15060484490157 - moorFLPI-2 Clinical PC Software: 2019-01-14 moorFLPI-2 Clinical PC Software V1
• 15060484490003 - Moor Instruments Ltd: 2018-07-06 moorVMS-LDF - Laser Doppler Perfusion and Temperature Monitor
• 15060484490010 - Moor Instruments Ltd: 2018-07-06 moorVMS-PRES - Pressure Cuff Controller
• 15060484490027 - Moor Instruments Ltd: 2018-07-06 moorMVS-OXY - Tissue Oxygen and Temperature Monitor
• 15060484490034 - Moor Instruments Ltd: 2018-07-06 moorFLPI - Full-Field Laser Perfusion Imager