HOME AIDE DIAGNOSTICS, INC.

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

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Filters

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) (5) Syringe, Piston (FMF) (2) Lancet, Blood (FMK) (1) Mouthpiece, Breathing (BYP) (1) Pad, Alcohol, Device Disinfectant (LKB) (1)

Premarket Exempt

No Yes

Clear

Pure Comfort Adult Inhaler Spacer Chamber - 00850027494418 Catalog Number : 4418

Device Description : Inaher Space Chamber with mask

Device Class : 1

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 1

True Comfort Safety Pen Needles 6MM 31G - 00850027494425 Catalog Number :

Device Description : Safety Pen Needles 6MM 31G

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Safety Pen Needles 5MM 31G - 00850027494432 Catalog Number :

Device Description : Safety Pen Needles 5MM 31G

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Safety Pen Needles 4MM 32G - 00850027494449 Catalog Number :

Device Description : Safety Pen Needles 4MM 32G

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

Pro Comfort Pen Needles 4mm - 00850632007003 Catalog Number : 7003

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

Pro Comfort Twist Top Lancets 30G - 00850632007010 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

Pro Comfort Insulin Syringes (1cc)(5/16")(30G) - 00850632007027 Catalog Number : 7027

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

Pro Comfort Alcohol Pads - 00850632007034 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

Pro Comfort Pen Needles 6mm - 00850632007041 Catalog Number : 7041

Device Description : 100ct box. 32G x 5/16 (6mm) Single use disposable pen needle for use with most i 100ct box. 32G x 5/16 (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

Pro Comfort Insulin Syringes (1cc)(5/16")(31G) - 00850632007058 Catalog Number : 7058

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

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