Moor Instruments Ltd

Basic Information

• Brand Name: Moor Instruments Ltd
• Primary DI: 15060484490034
• Version / Model: moorFLPI
• Company Name: MOOR INSTRUMENTS LIMITED
• Labeler DUNS: 398037580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 664c5c76-ddda-4c2b-b00b-2ca05b2c960d

Device Description

moorFLPI - Full-Field Laser Perfusion Imager

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	870.2120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58447	Cutaneous microcirculation laser Doppler imaging device	A mobile, mains electricity (AC-powered) device designed to use the laser Doppler imaging (LDI) technique of skin blood flow to visualize the perfusion of cutaneous microcirculation over a surface area. It typically consists of a dedicated camera system which includes a laser, an imaging sensor and electronics, mounted on a wheeled pedestal. The device works by non-invasively detecting the frequency change of the laser radiation reflected by the moving red blood cells in the small vessels. It is used in pre-, intra- [in the operating room (OR)], and postoperative clinical assessment, typically to evaluate burn wound healing potential, or for assessing reperfusion of cutaneous flaps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060484490034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063586	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius