Duns Number:963223677
Device Description: BP3T Blood pressure monitor with ARM CUFFAdvanced one-step operation. Push-Button access t BP3T Blood pressure monitor with ARM CUFFAdvanced one-step operation. Push-Button access to average blood pressure calculation. 4 AAA batteries and medium sized arm cuff.
Catalog Number
-
Brand Name
Ozeri
Version/Model Number
BP3T
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
441f7ba3-0648-4038-af25-2bf1aa3ec70c
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
October 26, 2017
Package DI Number
20815817012740
Quantity per Package
8
Contains DI Package
10815817012743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |