Moor Instruments Ltd

GUDID 15060484490058

moorLDI2 - Laser Doppler Imager (>= S/N 5700)

MOOR INSTRUMENTS LIMITED

Cutaneous microcirculation laser Doppler imaging device

• Primary Device ID: 15060484490058
• NIH Device Record Key: e5cbf5f1-7139-4a4c-b6b3-eb99344d4c53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moor Instruments Ltd
• Version Model Number: moorLDI2
• 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 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 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 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 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 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060484490058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152749

FDA Product Code

• DPT: Probe, Blood-Flow, Extravascular

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