FDA.reportPublic FDA data

HOME AIDE DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057508153008474962HOME AIDE DIAGNOSTICS, INC.1Y2027-01-011072 S Powerline Rd Deerfield Bch FL US 33442

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC" - 46548009150116info@homeaide.us
00850071765069Easy Comfort Safety Lancets 30G 100cnt - ECSLAN8009150116info@homeaide.us
00850632007263Pro Health Mini: Talking Blood Pressure Monitor - 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.1-800-915-0116info@homeaide.us
00860015635518Ultra-Care Disposable Safety Lancets 30G - Ultra-Care Disposable Safety Lancets 30G 100 lancets/box8009150116info@homeaide.us
00891237001195Easy Step Blood Glucose Test Strips 50ct - 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system1-800-915-0116info@homeaide.us
00891237001423Easy Trak Blood Glucose Test Strips 25ct - 25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monitoring system1-800-915-0116info@homeaide.us
00891237001485Easy Talk Blood Glucose Testing Strips 25ct - 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II monitoring systems1-800-915-0116info@homeaide.us
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct - 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk monitoring systems1-800-915-0116info@homeaide.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
768961684314246K181215Infrared ThermometerFLL2019-01-02
768961491589719K172989Electric Breast PumpHGX2017-12-20
768961216844609K163518Digital ThermometerFLL2017-09-19
768961280000569K133509EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOONBW2014-02-21
768961039351856K133058INSULIN PEN NEEDLEFMI2014-02-25
768961869158244K123030COMPRESSOR NEBULIZER MODEL MCN-S600XXCAF2013-12-19
768961827118486K121719SM TENS & PMSNGX2013-05-10
768961570771292K110421DISPOSABLE INSULIN SYRINGEFMF2011-04-26
768961051135969K100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277NBW2010-05-12
768961732909024K092546GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CMGXY2009-12-18
768961445523329K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMSNBW2009-06-04
768961096283486

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW32014-02-21
FLL22019-01-02
HGX12017-12-20
FMI12014-02-25
CAF12013-12-19
NGX12013-05-10
FMF12011-04-26
GXY12009-12-18

GUDID#

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