NISSEI

GUDID 04931140011334

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.

NIHON SEIMITSU SOKKI CO., LTD.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 04931140011334
• NIH Device Record Key: 64321446-83a0-43b4-8d76-d4f1f902ad76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NISSEI
• Version Model Number: DSK-1011
• Company DUNS: 690593702
• Company Name: NIHON SEIMITSU SOKKI CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Width: 4.5 Inch
• Width: 4.5 Inch
• Width: 4.5 Inch

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04931140011334 [Primary]
GS1	14931140011331 [Package]; Package: master carton [20 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-16

On-Brand Devices [NISSEI]

• 04931140061018: WSK-1011 is a wrist type blood pressure monitor. This product is intended for noninvasive measur
• 04931140011402: DSK-1031 is an upper arm type blood pressure monitor. This product is intended for noninvasive m
• 04931140011334: DSK-1011 is an upper arm type blood pressure monitor. This product is intended for noninvasive m