Duns Number:117652799
Device Description: Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile a Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Catalog Number
-
Brand Name
BlackBox RPM
Version/Model Number
BPM-201W
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2021
Issuing Agency
In HIBCC
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
1da0a14d-613f-4204-a6ee-c314bf66f7ed
Public Version Date
January 01, 2021
Public Version Number
2
DI Record Publish Date
October 12, 2020
Package DI Number
BB1BB963201W1
Quantity per Package
10
Contains DI Package
B963BPM201W1
Package Discontinue Date
January 01, 2021
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |