AccessGUDID - DEVICE: F-Scan Lite VersaTek (B970FVL10)

GUDID

Device Identifier (DI) Information

Brand Name: F-Scan Lite VersaTek
Version or Model: F-Scan Lite VersaTek System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FVL1
Company Name: Tekscan, Inc.

Primary DI Number: B970FVL10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 178180246 *Terms of Use

Device Description: Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 6 F-Scan 3000E Sensors, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Web-Based Training Session.

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):	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?
43829	Body-surface pressure mapping system	An assembly of electronic devices intended to be used to measure the contact pressure between the body surface and a pressure-sensing pad to provide a map of compression forces during planning of/preparation for personal mobility device use or body support device use by a patient. Described as pressure mapping technology (PMT), it includes a sensor pad and a dedicated computer/software for data analysis, and is typically used to customize the shape of a wheelchair seating cushion to reduce the risk of pressure sore development.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70112c96-67fd-463d-a0b2-7b9c602efa08
Public Version Date: November 19, 2020
Public Version Number: 2
DI Record Publish Date: November 03, 2020