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Nissei

FDA UDI

Class II (US FDA UDI)

by Nihon Seimitsu Sokki Co., Ltd.

Identity

Trade Name
NISSEI FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Device Name
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. FDA UDI
Model / Reference
DSK-1011 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04931140011334 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Depth — 2.6 Inch FDA UDI
Height — 4.5 Inch FDA UDI
Width — 4.5 Inch FDA UDI

Category: Automatic-inflation electronic sphygmomanometer, non-portable

Nissei by Nihon Seimitsu Sokki Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic-inflation electronic sphygmomanometer, non-portable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Seimitsu Sokki Co., Ltd.

Sources (1)

  • FDA UDI 64321446-83a0-43b4-8d76-d4f1f902ad76 35 fields · synced May 30, 2026