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) (5) Gastrointestinal Tubes With Enteral Specific Connectors (PIF) (2) Tubes, Gastrointestinal (And Accessories) (KNT) (2) Kit, Surgical Instrument, Disposable (KDD) (1) Needle, Aspiration And Injection, Disposable (GAA) (1) Suture Removal Kit (MCZ) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

Biotronix Healthcare - 00850005165279 Catalog Number : GEED53006

Device Description : Enteral Delivery Pump Bag Set w/ ENFit™* Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : PIF, KNT

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165286 Catalog Number : GEED53007

Device Description : Enteral Delivery Gravity Bag Set w/ ENFit™* Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : PIF, KNT

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Suture Removal Tray - 00850005165293 Catalog Number : OR4001

Device Description : Suture Removal Tray

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : MCZ, KDD

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Blunt Fill Needles with Filters - 00850005165316 Catalog Number : GEBF5006

Device Description : Blunt Fill Needle with Filters 18G x 1 1/2"

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00850005165798 Catalog Number : GE12035

Device Description : Disposable 3CC, LL Syringe W/Needle, 20G x 1", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00858835007004 Catalog Number : GE36419

Device Description : Disposable Hypodermic Needles 18G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00858835007011 Catalog Number : GE36420

Device Description : Disposable Hypodermic Needle 18G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00858835007028 Catalog Number : GE36418

Device Description : Disposable Hypodermic Needle 20G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00858835007035 Catalog Number : GE36416

Device Description : Disposable Hypodermic Needle 21G x 1 1/2

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00858835007042 Catalog Number : GE36412

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

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

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