BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Address:4720 Salisbury Road,Jacksonville,FL,32256,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) (3) Syringe, Piston (FMF) (3) Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (2) Catheter Care Tray (OHR) (1)

Premarket Exempt

No Yes

Clear

Biotronix Healthcare IV Catheters - 00858835007936 Catalog Number :

Device Description : IV CATHETER 22G X 1" Blue

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare IV Catheters - 00858835007943 Catalog Number :

Device Description : IV CATHETER 22G X 1 1/4" BLUE,

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Hypodermic Needles - 00858835007950 Catalog Number : GE36412

Device Description : DISPOSABLE HYPODERMIC NEEDLE 22G X 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Hypodermic Needles - 00858835007967 Catalog Number : GE36411

Device Description : DISPOSABLE HYPODERMIC NEEDLE 22G X 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Hypodermic Needles - 00858835007974 Catalog Number : GE36403

Device Description : HYPODERMIC NEEDLE 25G X 5/8"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Insulin Pen Needles - 00858835007981 Catalog Number :

Device Description : Insulin Pen Needle 31G x 3/16"(5mm), Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00864085000405 Catalog Number : GE12085

Device Description : Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00864085000412 Catalog Number : GE12041

Device Description : Disposable 3cc LL Syringe with Needle 23G x 1 1/2, Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Foley Trays - 00864085000498 Catalog Number : UR1416FT

Device Description : Pre-Connected Latex Foley Tray 16FR

Device Class : 2

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

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