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

Nebulizer (Direct Patient Interface) (CAF) (4) Catheter Care Tray (OHR) (2) Syringe, Irrigating (Non Dental) (KYZ) (2) Enema Kit (FCE) (1) Kit, Surgical Instrument, Disposable (KDD) (1)

Premarket Exempt

No Yes

Clear

Biotronix Healthcare Foley Trays - 00850005165002 Catalog Number :

Device Description : Pre-Connected Latex Foley Tray 18FR

Device Class : 2

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Urethral Catheter Trays - 00850005165019 Catalog Number : UR22014

Device Description : Intermittent Urethral Catheter Tray 14FR, PVC

Device Class : 2

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Enema Bag Set - 00850005165026 Catalog Number : GE41001

Device Description : Enema Bag Set

Device Class : 1

Duns Number: 065762392

Premarket Exempt : No

Product Code : FCE

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165033 Catalog Number : URHT18

Device Description : Irrigation Tray with Bulb Syringe

Device Class : 1

Duns Number: 065762392

Premarket Exempt : No

Product Code : KYZ

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165040 Catalog Number : URHT19

Device Description : Irrigation Tray with Piston Syringe

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : KYZ

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165057 Catalog Number : OR4004

Device Description : Minor Laceration Tray w/ Instrument

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165071 Catalog Number : RE-343002U

Device Description : Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Biotronis Healthcare - 00850005165088 Catalog Number : RE-343004U

Device Description : Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Universal Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165095 Catalog Number : RE-343002S

Device Description : Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare - 00850005165101 Catalog Number : RE-343004S

Device Description : Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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