Talking Sense Upper Arm Blood Pressure Monitor XL cuff 1829

GUDID 00891237001829

Audible results. Arm-type fully automatic digital blood pressure monitor. LCD digital display. Oscillometric measurement method. 0mmHg~300mmHg pressure range. 30-180 Beats/Minute. 3mmHg pressure accuracy. 5% pulse accuracy. Automatic Pressurization. 120 Memories in Four groups with date and time. low battery detection. Automatic Power-off. 4 AA batteries. Approximately 2 months at 3 test per day battery life. 22.0cm ~36.0cm (8.6" ~14.2") cuff cirfumference.

HOME AIDE DIAGNOSTICS, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00891237001829
NIH Device Record Keyb7de3b30-4cb6-4ef1-b0c2-bba8af739f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalking Sense Upper Arm Blood Pressure Monitor XL cuff
Version Model NumberBP-1303
Catalog Number1829
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-915-0116
Emailinfo@homeaide.us

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100891237001829 [Primary]
GS110891237001826 [Package]
Package: Case [24 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 Number4
Public Version Date2019-11-08
Device Publish Date2016-05-01

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