PENO LLC

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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

Applicator, Ent (KCJ) (2) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (1)

Premarket Exempt

No Yes

Clear

CLEARinse - B423CRPRO1 Catalog Number :

Device Description : The CLEARinse Pro is designed to make nasal and sinus lavage easy and convenient The CLEARinse Pro is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of saline into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can be used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement maneuver. The device consists of a hand held battery operated unit with a disposable tip portion. A charger is provided with the device.

Device Class : 2

Duns Number: 828917653

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

CLEARINSE - CRBFV1 Catalog Number :

Device Class : 1

Duns Number: 828917653

Premarket Exempt : Yes

Product Code : KCJ

Prescription Use : No

Device Count : 1

CLEARinse Nasal Aspirator - CRBFV2 Catalog Number :

Device Class : 1

Duns Number: 828917653

Premarket Exempt : Yes

Product Code : KCJ

Prescription Use : No

Device Count : 1

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