Duns Number:867673159
Device Description: Personal CareBP Monitor Product Description: BP Monitor, Auto, Wrist,5.3 x 8.5 1/e
Catalog Number
-
Brand Name
Drive
Version/Model Number
BP2200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 18, 2020
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
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
adf1e553-d256-491b-997a-13dbf8b4c5b8
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
February 11, 2020
Package DI Number
10890124000409
Quantity per Package
24
Contains DI Package
00890124000402
Package Discontinue Date
April 18, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |