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) (9) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

True Comfort Pro Pen Needles 8MM 31G - 00850027494005 Catalog Number : 1706

Device Description : 100ct box. 31G x (8mm) Single use disposable pen needle for use with most insuli 100ct box. 31G x (8mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 5MM 32G - 00850027494012 Catalog Number : 7102

Device Description : 100ct box. 32G x 5mm Single use disposable pen needle for use with most insulin 100ct box. 32G x 5mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 6MM 32G - 00850027494029 Catalog Number : 7041

Device Description : 100ct box. 32G x 6mm Single use disposable pen needle for use with most insulin 100ct box. 32G x 6mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 4MM 33G - 00850027494036 Catalog Number : 7447

Device Description : 4mm x 32G Single use disposable Pen needles. Includes 100 sterile needles indivi 4mm x 32G Single use disposable Pen needles. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 5MM 33G - 00850027494043 Catalog Number : 7454

Device Description : 5mm x 33G Single use disposable Pen needles. Includes 100 sterile needles indivi 5mm x 33G Single use disposable Pen needles. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 6MM 33G - 00850027494050 Catalog Number : 7461

Device Description : 6mmx33G Single use disposable Pen needles. Includes 100 sterile needles individu 6mmx33G Single use disposable Pen needles. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 4MM 32G - 00850027494067 Catalog Number : 1775

Device Description : 100ct box. 32G x 4mm Single use disposable pen needle for use with most insulin 100ct box. 32G x 4mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 5MM 31G - 00850027494074 Catalog Number : 1638

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

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Pen Needles 6MM 31G - 00850027494081 Catalog Number : 1737

Device Description : 100ct box. 31G x 6mm Single use disposable pen needle for use with most insulin 100ct box. 31G x 6mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

Device Class : 2

Duns Number: 783518983

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

True Comfort Pro Insulin Syringes 31G 1CC 5/16" - 00850027494098 Catalog Number :

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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