Duns Number:492177197
Device Description: BPM-317 digital blood pressure monitor for home use with one size fits all wrist cuff hel BPM-317 digital blood pressure monitor for home use with one size fits all wrist cuff helps to keep track of your blood pressure
Catalog Number
-
Brand Name
iProven
Version/Model Number
BPM-317
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"
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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
d5079003-8e93-41c8-8be4-4af63f36d484
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |