moorFLPI2- Measurement PC Software

GUDID 15060484490126

moorFLPI2- Measurement PC Software V2

MOOR INSTRUMENTS LIMITED

Cutaneous microcirculation laser Doppler imaging device Cutaneous microcirculation laser Doppler imaging device

• Primary Device ID: 15060484490126
• NIH Device Record Key: 14615eb4-b598-4e5f-9308-f47878bbe548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: moorFLPI2- Measurement PC Software
• Version Model Number: 2
• 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
• Phone: +44129735715
• Email: service@moor.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060484490126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122943

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: 2016-11-29

Devices Manufactured by MOOR INSTRUMENTS LIMITED

• 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