Duns Number:081060692
Catalog Number
RP-BPM001
Brand Name
renpho
Version/Model Number
RP-BPM001
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
1ec85d6b-c7a5-488a-9331-b3be13dc9788
Public Version Date
February 17, 2020
Public Version Number
3
DI Record Publish Date
September 19, 2019
Package DI Number
00860002249612
Quantity per Package
40
Contains DI Package
00860002249605
Package Discontinue Date
February 16, 2020
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |