Duns Number:963223677
Device Description: Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.
Catalog Number
BP6T
Brand Name
Ozeri
Version/Model Number
BP6T
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
ab82ccf5-0ff0-4763-867a-112937f6d76b
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
May 23, 2017
Package DI Number
20815817012689
Quantity per Package
18
Contains DI Package
10815817012682
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |