NISSEI - DSK-1011 is an upper arm type blood pressure - NIHON SEIMITSU SOKKI CO., LTD.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

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

Additional Identifiers

Package DI Number

14931140011331

Quantity per Package

20

Contains DI Package

04931140011334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master carton