HOME AIDE DIAGNOSTICS, INC.

Address:1072 S Powerline Rd,Deerfield Bch,FL,33442,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Test, Blood Glucose, Over The Counter (NBW) (4) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Nebulizer (Direct Patient Interface) (CAF) (1) Needle, Hypodermic, Single Lumen (FMI) (1) Orthosis, Limb Brace (IQI) (1) Splint, Hand, And Components (ILH) (1) Bedding, Disposable, Medical (KME) (1) Thermometer, Electronic, Clinical (FLL) (1) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

No Yes

Clear

Easy Talk Control Solution - LOW - 00891237001492 Catalog Number : 1492

Device Description : Blood glucose control solution for use with Easy Talk blood glucose testing system

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

Easy Talk Control Solution - HIGH - 00891237001522 Catalog Number : 1522

Device Description : Blood glucose control solution for use with Easy Talk blood glucose testing system

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

Comfort Shield Adult Underpads - 00891237001539 Catalog Number :

Device Description : • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of paddin • 150 underpads per box• Size: 30in x 36in• 28" wide pad• 60 grams of padding• 24" of padded protection• Extra absorbent underpads for incontinence• Provides excellent protection for beds and chairs• Absorbs well to prevent leakage• Reduces odors and maintains dryness

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 1

Oral Temp Digital Thermometer - 00891237001546 Catalog Number : 1546

Device Description : Features:~ Flexible tip for convenient use~ Accurate to ±0.1 °C / ±0.2 °F~ Water Features:~ Flexible tip for convenient use~ Accurate to ±0.1 °C / ±0.2 °F~ Waterproof~ Large easy-to-read LCD~ Last memory recall~ Fever alarm~ Low battery indicator~ Automatic shut-off~ For oral, rectal, or axillary use

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

True Support Orthopedic Wrist Brace - 00891237001591 Catalog Number : 1591

Device Description : • Fully adjustable VELCRO allows for universal fit• Ideal treatment for: - Car • Fully adjustable VELCRO allows for universal fit• Ideal treatment for: - Carpal tunnel syndrome- Arthritis- Mild strains or sprains• Provides support to weak or injured wrists• Improves wrist joint function• Available for Right or Left wrist

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

Easy Air Compressor Nebulizer - 00891237001607 Catalog Number : 1607

Device Description : Your Nebulizer is intended for use in the treatment of asthma, COPD and other re Your Nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. Please consult with your physician and/or pharmacist to determine if your prescription medication is approved for use with this Nebulizer. This Nebulizer is intended for single patient use.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

Knee Support Orthopedic Knee Brace - 00891237001614 Catalog Number : 1614

Device Description : • Thermal neoprene sleeves• Adjustable VELCRO straps• Fits right or left knee • Thermal neoprene sleeves• Adjustable VELCRO straps• Fits right or left knee• Rigid uprights for support• Stabilize collateral ligaments• Decreases pain symptoms• Improves joint function• Stabilizes knee joint• Help with Arthritic knee pain

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Easy Comfort Pen Needles 5mm - 00891237001638 Catalog Number : 1638

Device Description : 100ct box. 31G x 3/16 (5mm) Single use disposable pen needle for use with most i 100ct box. 31G x 3/16 (5mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Easy Plus II Blood Glucose Testing Strips 25ct - 00891237001645 Catalog Number : 1645

Device Description : 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk monitoring systems

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

Easy Plus II Blood Glucose Monitoring System - 00891237001652 Catalog Number : 1652

Device Description : Blood Glucose Testing Monitor to be used with Easy Plus II or Easy Talk test str Blood Glucose Testing Monitor to be used with Easy Plus II or Easy Talk test stripsTest: GlucoseSample: Whole BloodPrinciple of the test method: Amperometric, glucose oxidaseTest sites: Fingertip, forearmMeasurement time: 6 secondsCode required: No code deviceMeasurement Range: 20~600 mg/dL (1.1~33.3mmol/L ).Batteries: 2 x AAA 1.5 V Alkaline 24A LR03

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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