Duns Number:537208717
Device Description: Mercury sphygmomanometers for non invasive measurement of arterial blood pressure.
Catalog Number
1000
Brand Name
diplomat-presameter® desk, light grey, adult size bandage cuff
Version/Model Number
1000
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
K943461
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
9c0f3e52-da46-45bf-b840-a2b46304e8f3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 29, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 282 |
2 | A medical device with a moderate to high risk that requires special controls. | 332 |