DEVICE: NISSEI (04931140011402)

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Device Identifier (DI) Information

NISSEI
DSK-1031

NIHON SEIMITSU SOKKI CO., LTD.
04931140011402
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Automatic-inflation electronic sphygmomanometer, non-portable A mains electricity (AC-powered) electronic device, typically digital, 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.
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FDA Product Code

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

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14931140011409 20 04931140011402 In Commercial Distribution master carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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