PURACATH MEDICAL, INC

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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

Set, Administration, For Peritoneal Dialysis, Disposable (KDJ) (4)

Premarket Exempt

Clear

Firefly UV Disinfection Device - 00865349000308 Catalog Number :

Device Description : Battery powered Ultraviolet light disinfection device.

Device Class : 2

Duns Number: 963236661

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Firefly Transfer Catheter - 00865349000315 Catalog Number :

Device Description : Perotineal Dialysis Transfer Catheter

Device Class :

Duns Number: 963236661

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Firefly Luer Cover - 00865349000339 Catalog Number :

Device Description : Luer Cap for the Firefly Transfer Catheter

Device Class :

Duns Number: 963236661

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Firefly IPA Bottle - 00865349000353 Catalog Number :

Device Description : 99% IPA bottle for use with the Firefly system

Device Class : 2

Duns Number: 963236661

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

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