AccessGUDID - DEVICE: NISSEI (04931140011402)

GUDID

Device Identifier (DI) Information

Brand Name: NISSEI
Version or Model: DSK-1031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIHON SEIMITSU SOKKI CO., LTD.

Primary DI Number: 04931140011402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690593702 *Terms of Use

Device Description: DSK-1031 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 deflation of the cuff. The cuff is automatically inflated rapidly to the pressure value sufficiently above the systolic value before it shifts to the gradual deflation for measurement. The masurement ends after the diastolic blood pressure is determined and then the measurement result is displayed. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, Cuff Application check, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Depth: 2.6 Inch
Width: 4.5 Inch
Height: 4.5 Inch

Device Record Status

Public Device Record Key: 40c03554-ef99-4f88-842e-8f8ccd88450b
Public Version Date: November 08, 2019
Public Version Number: 3
DI Record Publish Date: September 16, 2016