DYNAREX CORPORATION

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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

Monitor, Bed Patient (KMI) (5) Catheter Care Tray (OHR) (3) Device, Fixation, Tracheal Tube (CBH) (1) Set, Administration, Intravascular (FPA) (1)

Premarket Exempt

No Yes

Clear

Dressing Change Tray, Sterile - 00860008059536 Catalog Number :

Device Description : Dressing Change Tray, Sterile

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : No

Device Count : 20

IV Start Kit with Nitrile Gloves - 00860008059543 Catalog Number :

Device Description : IV Start Kit with Gloves

Device Class : 2

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Tracheostomy Care Tray with Gloves - 00860008059567 Catalog Number :

Device Description : Tracheostomy Care Tray with Gloves, Sterile

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 20

Closed Circuit Foley Catheter - 00860008059574 Catalog Number : 5005

Device Description : Closed Circuit Foley Catheter, Sterile 14 Fr.

Device Class : 2

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : OHR

Prescription Use : No

Device Count : 1

Silicone Foley Catheter insertion Kit - 12 Fr - 00860008059581 Catalog Number :

Device Description : Silicone Foley Catheter Insertion Kit - 12Fr

Device Class :

Duns Number: 008124539

Premarket Exempt : No

Product Code : OHR

Prescription Use : No

Device Count : 10

Dynarex Protech String Monitor - 10852685007044 Catalog Number :

Device Description : Protech String Monitor

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 40

Dynarex Protech Mobile Monitor - 10852685007051 Catalog Number :

Device Description : Protech Mobile Monitor

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 40

Dynarex Protech Flex Monitor - 10852685007068 Catalog Number :

Device Description : Protech Flex Monitor

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 40

Dynarex Protech Voice Monitor - 10852685007075 Catalog Number :

Device Description : Protech Voice Monitor

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 40

Dynarex Protech Ultra Monitor - 10852685007082 Catalog Number :

Device Description : Protech Ultra Monitor, Ultra Alarm, with 3 way functionality

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 40

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