Sunbean

GUDID 14719872483295

Upper Arm Blood Pressure Monitor

HEALTH & LIFE CO., LTD.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID14719872483295
NIH Device Record Key79f0a2df-4e8c-4987-a986-9e6141bf362c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunbean
Version Model NumberHL858A2-LT
Company DUNS657836743
Company NameHEALTH & LIFE CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872483298 [Primary]
GS114719872483295 [Package]
Contains: 04719872483298
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-19
Device Publish Date2021-10-11

Devices Manufactured by HEALTH & LIFE CO., LTD.

14719872486043 - ALERTCARE2023-08-14 Nebulizer
04719872483380 - PRESTIGE2023-06-13 Arm type blood pressure monitor
14719872489198 - Homedics2023-02-23 Blood pressure cuff of the blood pressure monitor
14719872489181 - N/A2021-12-22 Blood pressure cuff of the blood monitor
14719872483295 - Sunbean2021-10-19Upper Arm Blood Pressure Monitor
14719872483295 - Sunbean2021-10-19 Upper Arm Blood Pressure Monitor
14719872489167 - Homedics2021-10-14 Blood pressure cuff of the blood pressure monitor
14719872489174 - N/A2021-10-14 Blood pressure cuff of the blood pressure monitor
14719872483271 - HM012021-08-10 Arm type blood pressure monitor

Trademark Results [Sunbean]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUNBEAN
SUNBEAN
97741369 not registered Live/Pending
ITC Limited
2023-01-04
SUNBEAN
SUNBEAN
97741286 not registered Live/Pending
ITC Limited
2023-01-04
SUNBEAN
SUNBEAN
90899213 not registered Live/Pending
Sunbean
2021-08-24

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