Duns Number:189583599
Device Description: Bluetooth Blood Pressure Monitor
Catalog Number
-
Brand Name
Greater Goods
Version/Model Number
0664
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
K131395,K131395
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
30687961-289f-4605-9615-2481b9ce0161
Public Version Date
November 11, 2020
Public Version Number
1
DI Record Publish Date
November 03, 2020
Package DI Number
10875011006641
Quantity per Package
12
Contains DI Package
00875011006644
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |