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) Pad, Alcohol, Device Disinfectant (LKB) (3) Flowmeter, Tube, Thorpe, Back-Pressure Compensated (CAX) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

Yes No

Clear

ZevRx STERILE PEN NEEDLES 8mm 31G - 00850632007799 Catalog Number :

Device Description : ZevRx STERILE PEN NEEDLES 8mm 31GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXS ZevRx STERILE PEN NEEDLES 8mm 31GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXSINGLE USE DISPOSABLE NEEDLEUNIVERSAL FIT FOR MOST PEN SYSTEMS

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

ZevRx STERILE PEN NEEDLES 4mm 32G - 00850632007805 Catalog Number :

Device Description : ZevRx STERILE PEN NEEDLES 4mm 32GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXS ZevRx STERILE PEN NEEDLES 4mm 32GINDIVIDUALLY SEALED100 STERILE NEEDLES / BOXSINGLE USE DISPOSABLE NEEDLEUNIVERSAL FIT FOR MOST PEN SYSTEMS

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

ZevRx STERILE INSULIN SYRINGE 5/16” 1/2CC 30G - 00850632007829 Catalog Number :

Device Description : ZevRx STERILE INSULIN SYRINGE 5/16” 1/2CC 30G100 SYRINGES / BOXINDIVIDUALLY WRAPPED

Device Class :

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Easy Comfort Alcohol Pads 50 count - 00860000526579 Catalog Number :

Device Description : • 2-ply pads• Saturated with 70% isopropyl alcohol• 50 individually packed al • 2-ply pads• Saturated with 70% isopropyl alcohol• 50 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

SAPS health + Alcohol Pads - 00860000526586 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

Pure Comfort Peak Flow Meter ADULT - 00860000526593 Catalog Number :

Device Description : Peak flow meter for adult use

Device Class :

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : CAX

Prescription Use : No

Device Count : 1

Pure Comfort Alcohol Pads - 00860003125502 Catalog Number :

Device Class : U

Duns Number: 783518983

Premarket Exempt : Yes

Product Code : LKB

Prescription Use : No

Device Count : 1

Pure Comfort Insulin Pen Needles 32G 4mm 50cnt - 00860003125519 Catalog Number :

Device Description : Insulin Pen Needles 32G 4mm 50cnt

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

Pure Comfort Insulin Pen Needles 32G 5mm 50cnt - 00860003125526 Catalog Number :

Device Description : Insulin Pen Needles 32G 5mm 50cnt

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

Pure Comfort Insulin Pen Needles 32G 6mm 50cnt - 00860003125533 Catalog Number :

Device Description : Insulin Pen Needles 32G 6mm 50cnt

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

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