FDA.reportPublic FDA data

Dario Smart Scale (Cellular) - Weight Management System

Primary DI
00850033352023
Brand
Dario Smart Scale (Cellular) - Weight Management System
Company
DARIOHEALTH CORP.
Model
1169-05
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.
Published
2021-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033352023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033352023008500333520238500333520230850033352023

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116902485
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033352184Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System1268-052026-01-05
00850033352191Dario Smart Scale (Cellular)- Wight Management System1269-052025-10-15
00850033352061Dario Smart Blood Pressure Monitor Gen 21217-052022-06-27
00850033352092Dario Smart Scale1166-052022-06-26
00850033352009Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System1168-052021-08-09
00850033352078Dario Blood Pressure Monitoring System (Large cuff) 1165-052021-11-07
00850033352085Dario Blood Pressure Monitoring System (M cuff) 1160-052021-11-07
00850065006345Dario Blood Pressure Monitoring System (M cuff)TD-31282020-01-23
00850065006437Dario Blood Pressure Monitoring System (Large cuff)TD-31282020-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987003761SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003778SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003785SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003792SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003808SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003815SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003822SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003839SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987000029SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000036SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000135SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000142SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000159SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000166SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000173SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000180SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000197SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000203SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000210SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000258SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000265SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000449SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000777SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000784SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000791SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000807SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001033SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001040SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001057SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001064SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23