moorVMS-PC Software

Basic Information

• Brand Name: moorVMS-PC Software
• Primary DI: 15060484490096
• Version / Model: 4
• Company Name: MOOR INSTRUMENTS LIMITED
• Labeler DUNS: 398037580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ddb321f1-cdb3-4b5c-908f-b4b7197a44b5

Device Description

moorVMS-PC Software V4.0 is a Windows based software package designed to work with the moorVMS setup and is fully compatible with all of the existing modules.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	870.2100	2
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46615	Tissue saturation oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.	No	Active
60451	Laser Doppler blood flowmeter	A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060484490096	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083082	000
K102433	000
K112826	000