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) (9) Syringe, Piston (FMF) (8) Syringe, Antistick (MEG) (7) Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (1)

Premarket Exempt

No Yes

Clear

Biotronix Healthcare - 00858835007059 Catalog Number : GE36408

Device Description : Disposable Hypodermic Needles 23G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare IV Catheters - 00858835007066 Catalog Number :

Device Description : Disposable I.V. Catheter 24G x 3/4",Yellow

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007073 Catalog Number : BIO-1012S

Device Description : Disposable BioGuard Safety Needles 18G x 1 1/2",

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007080 Catalog Number : BIO-1024S

Device Description : Disposable BioGuard Safety Needles 22G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007097 Catalog Number : BIO-1044S

Device Description : Disposable BioGuard Safety Needles 30G x 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007103 Catalog Number : BIO-1051S

Device Description : Disposable 3cc Syringe LL, W/BioGuard Safety Needle 21G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF, FMI, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007110 Catalog Number : BIO-12301S

Device Description : Disposable Bioguard Safety Needles 23G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF, FMI, MEG

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007127 Catalog Number : BIO-1052S

Device Description : Disposable 3cc Syringe LL, W/BioGuard Safety Needle 21G x 1 1/2", Each

Device Class :

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007134 Catalog Number :

Device Description : Disposable 3cc Syringe LL, W/BioGuard Safety Needle 22G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007141 Catalog Number : BIO-1054S

Device Description : Disposable 3cc Syringe LL, W/BioGuard Safety Needle 22G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

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