Duns Number:117533826
Device Description: Cellular Blood Pressure Monitor
Catalog Number
-
Brand Name
HealthClix
Version/Model Number
HC-803
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
f96b9639-b8e4-4330-bb69-f076a8f08ac8
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 13, 2021
Package DI Number
10860008004007
Quantity per Package
10
Contains DI Package
00860008004000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |