gudid Primary ID: Pro

CLEARinse (UDI Pro)

Manufactured by PENO LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The CLEARinse (Model/Catalog Number: Pro) is a medical device manufactured by PENO LLC. This product is indexed under FDA Product Code / Category Classification JCX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Pro
Product Code / EMDN: JCX
Device Name: 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.
Database Sync Date: 2026-08-09 09:34:55

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of CLEARinse?

The registered manufacturer of record for CLEARinse is PENO LLC.

What is the Primary UDI-DI identifier for CLEARinse?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Pro.

What classification code is assigned to this device?

This device is registered under product classification code JCX.

Similar Classification Devices (JCX)

Other Devices by PENO LLC

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