Duns Number:069233103
Device Description: Automatic Arm Blood Pressure Monitor Large Cuff
Catalog Number
-
Brand Name
Slight Touch
Version/Model Number
St-402
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
b53f035e-fcf6-4f70-a2c7-5ff6cb32ec48
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 2016
Package DI Number
10862478000329
Quantity per Package
24
Contains DI Package
00862478000322
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. | 2 |