Duns Number:867673159
Device Description: Personal CareBP Monitor Product Description: BP Monitor,Auto,Upper Arm,8.6 - 14,1/ea
Catalog Number
-
Brand Name
Drive
Version/Model Number
BP2400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2019
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
2f598d00-6d86-4141-85cf-dc10ed0db34f
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
June 21, 2019
Package DI Number
50890124000421
Quantity per Package
24
Contains DI Package
00890124000426
Package Discontinue Date
June 21, 2019
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 |