Duns Number:076059836
Device Description: Good Sense Automatic Wrist Digital BP Unit
Catalog Number
-
Brand Name
Good Sense
Version/Model Number
69-556
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
ed1f7610-c242-4e5f-9466-0bc16692da78
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10846036007357
Quantity per Package
12
Contains DI Package
30846036007351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |