Duns Number:963223677
Device Description: Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to weigh up t Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology.Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- Black.This scale is not for clinical or diagnostic use.
Catalog Number
-
Brand Name
Ozeri
Version/Model Number
ZB13
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
a7c0edf8-98ac-4674-bd51-cae9c6d8cd04
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 17, 2017
Package DI Number
10815817012323
Quantity per Package
1
Contains DI Package
00815817012326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Gift box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |