Duns Number:079389709
Device Description: Bluetooth Blood Pressure MonitorUpper-arm blood pressure monitor intended to measure and m Bluetooth Blood Pressure MonitorUpper-arm blood pressure monitor intended to measure and monitor the arterial blood pressure values and the heart rates of adults with an arm circumference of 8.7 in to16.5 in (22cm to 42cm), in a non-invasive way.
Catalog Number
659.59
Brand Name
Silvercrest
Version/Model Number
IAN: 326870_1901
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"
Yes
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
29313fc3-d787-433a-b78b-2181aafeaa47
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
September 02, 2019
Package DI Number
14056232708217
Quantity per Package
4
Contains DI Package
04056232708210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case pack
| 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. | 11 |