Duns Number:658023275
Device Description: BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human syst BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.
Catalog Number
-
Brand Name
TekCare Blood Pressure Monitor
Version/Model Number
BPM19
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
dcaf65c1-ec35-4ed8-a18b-eff56ec5c240
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
December 31, 2018
Package DI Number
04710953421345
Quantity per Package
40
Contains DI Package
04710953421338
Package Discontinue Date
-
Package Status
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. | 7 |