AccessGUDID - DEVICE: FeetMe Monitor FTM-DK (03760349820048)

GUDID

Device Identifier (DI) Information

Brand Name: FeetMe Monitor FTM-DK
Version or Model: PVT2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FEETME

Primary DI Number: 03760349820048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 265478109 *Terms of Use

Device Description: FeetMe Monitor Medical device corresponding to a pair of connected insoles Model FTM-DK and version PVT2

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
61782	Pressure monitoring insole	A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFC	System, Pressure Measurement, Intermittent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: EU-36
Device Size Text, specify: EU-35
Device Size Text, specify: EU-37
Device Size Text, specify: EU-38
Device Size Text, specify: EU-39
Device Size Text, specify: EU-40
Device Size Text, specify: EU-41
Device Size Text, specify: EU-42
Device Size Text, specify: EU-43
Device Size Text, specify: EU-44
Device Size Text, specify: EU-45
Device Size Text, specify: EU-46

Device Record Status

Public Device Record Key: 5d2b2b7f-7b8f-459e-8f19-bf068b1db261
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 11, 2022