Duns Number:079389709
Device Description: Bluetooth Blood Pressure Monitor (SBM69)Upper-arm blood pressure monitor intended to measu Bluetooth Blood Pressure Monitor (SBM69)Upper-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
653.18
Brand Name
Silvercrest
Version/Model Number
IAN: 366723_2101
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)
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
640c5851-53b9-4187-8dcf-9bb78eca0413
Public Version Date
July 08, 2021
Public Version Number
1
DI Record Publish Date
June 30, 2021
Package DI Number
14055334329481
Quantity per Package
4
Contains DI Package
04055334329484
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 |