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

Needle, Hypodermic, Single Lumen (FMI) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Syringe, Piston (FMF) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2) Lancet, Blood (FMK) (1)

Premarket Exempt

No Yes

Clear

Easy Plus II Control Solution - LOW - 00891237001676 Catalog Number : 1676

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

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : No

Device Count : 1

Easy Plus II Control Solution - HIGH - 00891237001683 Catalog Number : 1683

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

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : NBW, JJX

Prescription Use : No

Device Count : 1

Easy Comfort Pen Needles 8mm - 00891237001706 Catalog Number : 1706

Device Description : 100ct box. 31G x 5/16 (8mm) Single use disposable pen needle for use with most i 100ct box. 31G x 5/16 (8mm) 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 Comfort Insulin Syringes (1/2cc)(1/2")(30G) - 00891237001713 Catalog Number : 1713

Device Description : (1/2cc)(1/2")(30G) Single use disposable insulin syringes. Includes 100 sterile (1/2cc)(1/2")(30G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Easy Comfort Insulin Syringes (1cc)(1/2")(30G) - 00891237001720 Catalog Number : 1720

Device Description : (1cc)(1/2")(30G) Single use disposable insulin syringes. Includes 100 sterile ne (1cc)(1/2")(30G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Easy Comfort Pen Needles 6mm - 00891237001737 Catalog Number : 1737

Device Description : 100ct box. 31G x 1/4 (6mm) Single use disposable pen needle for use with most in 100ct box. 31G x 1/4 (6mm) 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

Health Sense Upper Arm Blood Pressure Monitor XL cuff - 00891237001744 Catalog Number : 1744

Device Description : Arm-type fully automatic digital blood pressure monitor. LCD digital display. Os 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.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

SAPS Care Twist Top Lancets 30G - 00891237001751 Catalog Number :

Device Description : • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testi • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfort depth penetration• Smooth tri-bevel point• 100 sterile tip lancets per box

Device Class : 2

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Easy Comfort Pen Needles 4mm - 00891237001775 Catalog Number : 1775

Device Description : 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most i 100ct box. 32G x 5/32 (4mm) 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

Talking Sense Upper Arm Blood Pressure Monitor - 00891237001782 Catalog Number : 1782

Device Description : Audible Results. Arm-type fully automatic digital blood pressure monitor. LCD di 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 circumference.

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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