Moor Instruments Ltd

GUDID 15060484490027

moorMVS-OXY - Tissue Oxygen and Temperature Monitor

MOOR INSTRUMENTS LIMITED

Tissue saturation oximeter

• Primary Device ID: 15060484490027
• NIH Device Record Key: 5fe4b872-ae48-4d82-8366-eb229a485921
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moor Instruments Ltd
• Version Model Number: moorVMS-OXY
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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
• Phone: +44129735715
• Email: service@moor.co.uk

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060484490027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112826

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-08

On-Brand Devices [Moor Instruments Ltd]

• 15060484490140: Non-sterile Oxygenation, and Laser Doppler combined Probes
• 15060484490133: Non-sterile Laser Doppler Probes
• 15060484490089: moorLDLS-BI - Laser Doppler Line Scanner, Burns Imaging System
• 15060484490072: moorLDI2-BI - Laser Doppler Imager, Burns Imaging System
• 15060484490065: moorLDLS - Laser Doppler Line Scanner
• 15060484490058: moorLDI2 - Laser Doppler Imager (>= S/N 5700)
• 15060484490041: moorFLPI2 - Full-Field Laser Perfusion Imager
• 15060484490034: moorFLPI - Full-Field Laser Perfusion Imager
• 15060484490027: moorMVS-OXY - Tissue Oxygen and Temperature Monitor
• 15060484490010: moorVMS-PRES - Pressure Cuff Controller
• 15060484490003: moorVMS-LDF - Laser Doppler Perfusion and Temperature Monitor