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

Syringe, Piston (FMF) (7) Lancet, Blood (FMK) (1) Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (CCQ) (1) Pad, Alcohol, Device Disinfectant (LKB) (1)

Premarket Exempt

No Yes

Clear

True Comfort Pro Insulin Syringes 31G 1/2CC 5/16" - 00850027494104 Catalog Number :

Device Description : (1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile (1/2cc)(5/16")(31G) 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

True Comfort Pro Insulin Syringes 32G 1/2CC 5/16" - 00850027494111 Catalog Number :

Device Description : (1/2cc)(5/16")(32G) Single use disposable insulin syringes. Includes 100 sterile (1/2cc)(5/16")(32G) 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

True Comfort Pro Alcohol Pads - 00850027494128 Catalog Number :

Device Description : • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed a • 2-ply pads• Saturated with 70% isopropyl alcohol• 100 individually packed alcohol pads per box• For external use only

Device Class : U

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : LKB

Prescription Use : No

Device Count : 1

True Comfort Pro Twist Top Lancets 30G - 00850027494135 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

True Comfort Pro Insulin Syringes 32G 1CC 5/16" - 00850027494142 Catalog Number :

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

True Comfort Pro Insulin Syringes 30G 1cc 5/16" - 00850027494159 Catalog Number :

Device Description : (1cc)(5/16")(30G) Single use disposable insulin syringes. Includes 100 sterile n (1cc)(5/16")(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

True Comfort Pro Insulin Syringes 30G 1/2cc 5/16" - 00850027494166 Catalog Number :

Device Description : (1/2cc)(5/16")(30G) Single use disposable insulin syringes. Includes 100 sterile (1/2cc)(5/16")(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

True Comfort Pro Insulin Syringes 30G 1/2cc 1/2" - 00850027494173 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

True Comfort Pro Insulin Syringes 30G 1cc 1/2" - 00850027494180 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

Ultrasonic Mini Nebulizer - 00850027494364 Catalog Number :

Device Description : 12ml ultrasonic, portable, nonventilatory atomizer mini nebulizer

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : CCQ

Prescription Use : No

Device Count : 1

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