AccessGUDID - DEVICE: Dario Smart Scale (Cellular) - Weight Management System (00850033352023)

GUDID

Device Identifier (DI) Information

Brand Name: Dario Smart Scale (Cellular) - Weight Management System
Version or Model: 1169-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DARIOHEALTH CORP.

Primary DI Number: 00850033352023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116902485 *Terms of Use

Device Description: The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (aged 10-17 years old). It is intended for indoor use only.

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):	Yes
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
FRI	Scale, Stand-On, Patient

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: b714da12-7400-41ad-b746-6f6df03d85ed
Public Version Date: June 28, 2022
Public Version Number: 3
DI Record Publish Date: October 17, 2021