TekCare Blood Pressure Monitor

GUDID 04710953421345

BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.

AVITA CORPORATION

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID04710953421345
NIH Device Record Keydcaf65c1-ec35-4ed8-a18b-eff56ec5c240
Commercial Distribution StatusIn Commercial Distribution
Brand NameTekCare Blood Pressure Monitor
Version Model NumberBPM19
Company DUNS658023275
Company NameAVITA CORPORATION
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104710953421338 [Primary]
GS104710953421345 [Package]
Contains: 04710953421338
Package: [40 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-12-31

Devices Manufactured by AVITA CORPORATION

04710953421635 - Harbor Freight Tools2020-10-21 The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The m
04710953421604 - TekCare Non-Contact Infrared Thermometer2020-05-25 The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment an
04710953421529 - TekCare Touch Free Infrared Thermometer2020-04-23 The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domesti
04710953421468 - TekCare Green-Type Infrared Thermometer2019-12-09 The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.
04710953420942 - Blood pressure monitor2019-11-08 The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and
04710953421161 - Blood pressure monitor2019-11-08 The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pu
04710953421345 - TekCare Blood Pressure Monitor2019-11-08BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.
04710953421345 - TekCare Blood Pressure Monitor2019-11-08 BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and he
04710953421307 - TekCare Touch Free Infrared Thermometer2019-01-31 The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic

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