Primary Device ID | 00850033352092 |
NIH Device Record Key | 4d52e043-3431-4732-a5bf-bc44b40b2136 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dario Smart Scale |
Version Model Number | 1166-05 |
Company DUNS | 116902485 |
Company Name | DARIOHEALTH CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850033352092 [Primary] |
FRI | Scale, Stand-On, Patient |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-04 |
Device Publish Date | 2022-06-26 |
00850033352061 - Dario Smart Blood Pressure Monitor Gen 2 | 2022-07-05 The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumf |
00850033352092 - Dario Smart Scale | 2022-07-04The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit for the Dario Smart Scale is 396 lbs. (180 kg). |
00850033352092 - Dario Smart Scale | 2022-07-04 The Dario Smart Scale will accurately measure the weight of children and adults over 20 lbs. (9 kg). The maximum weight limit fo |
00850033352078 - Dario Blood Pressure Monitoring System (Large cuff) | 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse |
00850033352085 - Dario Blood Pressure Monitoring System (M cuff) | 2021-11-15 The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse |
00850065006345 - Dario Blood Pressure Monitoring System (M cuff) | 2020-01-31 |
00850065006437 - Dario Blood Pressure Monitoring System (Large cuff) | 2020-01-31 |