AccessGUDID - DEVICE: Profile by Sanford (00811392021029)

GUDID

Device Identifier (DI) Information

Brand Name: Profile by Sanford
Version or Model: LS206-E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROFILE PRODUCTS, LLC

Primary DI Number: 00811392021029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080392779 *Terms of Use

Device Description: The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.

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?
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNW	Analyzer, Body Composition

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123781	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
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Humidity: more than 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 12.5 Inch
Length: 12.5 Inch
Height: 1 Inch

Device Record Status

Public Device Record Key: 6953e457-8d21-455c-bef0-0b13c910dadc
Public Version Date: August 31, 2023
Public Version Number: 4
DI Record Publish Date: July 31, 2017