Duns Number:116902485
Device Description: The Dario Smart Scale will accurately measure the weight of children and adults over 20 lb The 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).
Catalog Number
-
Brand Name
Dario Smart Scale
Version/Model Number
1166-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRI
Product Code Name
Scale, Stand-On, Patient
Public Device Record Key
4d52e043-3431-4732-a5bf-bc44b40b2136
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 26, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |