AccessGUDID - DEVICE: moorVMS-VASC PC Software (15060484490102)

GUDID

Device Identifier (DI) Information

Brand Name: moorVMS-VASC PC Software
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOOR INSTRUMENTS LIMITED

Primary DI Number: 15060484490102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 398037580 *Terms of Use

Device Description: Clinical software for micro vascular assessments in physiological research and clinical applications.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPW	Flowmeter, Blood, Cardiovascular
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083082	000
K102433	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4fe92ca6-fd4b-4531-a7de-048ee6f6c18f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 24, 2016