Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System

GUDID 00850033352009

The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only

LABSTYLE INNOVATION LTD

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00850033352009
NIH Device Record Keya93b384a-5fcc-4293-b3a2-fcd50ac5f019
Commercial Distribution StatusIn Commercial Distribution
Brand NameDario Smart Monitor (Cellular) - Blood Pressure Monitoring System
Version Model Number1168-05
Company DUNS600039072
Company NameLABSTYLE INNOVATION LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033352009 [Primary]
GS100850033352016 [Package]
Package: Box [10 Units]
In Commercial Distribution

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 Date2021-08-17
Device Publish Date2021-08-09

Devices Manufactured by LABSTYLE INNOVATION LTD

00850065006741 - Dario® USB-C Blood Glucose Monitoring System- Welcome Kit2023-12-29 The Dario USB-C Blood Glucose Monitoring System Welcome Kit is a compact, all-in-one blood glucose meter that is used in conjunc
00850065006758 - Dario® USB-C Blood Glucose Monitoring System - Starter Kit2023-12-29 The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a
00850033352023 - Dario Smart Scale (Cellular) - Weight Management System2021-10-25 The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (ag
00850065006222 - Dario 100 Sterile Lancets2021-08-18 The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancin
00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System2021-08-17The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only
00850033352009 - Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System2021-08-17 The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pr
00850065006659 - Dario Super Saver MIB-Supplies2021-07-23
00850065006567 - Dario 300 Test Strips Bundle2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in
00850065006574 - Dario 200 Test Strips Bundle2020-09-03 The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.