N/A

GUDID 14719872489037

Standard Size Cuff with Connector for BPA-040

HEALTH & LIFE CO., LTD.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID14719872489037
NIH Device Record Key5eacae9b-b2f0-4f11-a1a1-fd4f5cdbbfbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberPP-BPCUFF21
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
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872489030 [Primary]
GS114719872489037 [Package]
Contains: 04719872489030
Package: [50 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2018-03-05

On-Brand Devices [N/A]

14719872489112Adaptor/ Efficiency Level VI
14719872489105Blood pressure cuff of the blood pressure monitor
14719872489082Blood pressure cuff of the blood pressure monitor
14719872489075Blood pressure cuff of the blood pressure monitor
04719872489061Blood pressure cuff of the arm type blood pressure monitor
14719872489051Blood pressure cuff of the blood pressure monitor
14719872489044Blood pressure cuff of the blood pressure monitor
14719872489037Standard Size Cuff with Connector for BPA-040
14719872489020Blood pressure cuff of the blood pressure monitor
14719872489013Blood pressure cuff of the blood pressure monitor
14719872489150Blood Pressure adapter of the blood pressure monitor
14719872489174Blood pressure cuff of the blood pressure monitor
14719872489181Blood pressure cuff of the blood monitor

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.