Duns Number:690593702
Device Description: DSK-1011 is an upper arm type blood pressure monitor. This product is intended for noninva DSK-1011 is an upper arm type blood pressure monitor. This product is intended for noninvasive measurement of systolic and diastolic blood pressure and pulse rate as well as calculation of pulse pressure in adults in a home healthcare environment. The product is not designed for neonatal use.Measurement is performed during the inflation of the cuff. The cuff is automatically inflated rapidly at the initial phase then gradually afterwards. The masurement ends as the systolic blood pressure is determined and then the measurement result is displayed. The initial rapid inflation value is set by the readings of the last three measurements by the function so-called Personal Mode. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.
Catalog Number
-
Brand Name
NISSEI
Version/Model Number
DSK-1011
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
64321446-83a0-43b4-8d76-d4f1f902ad76
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
14931140011331
Quantity per Package
20
Contains DI Package
04931140011334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master carton