gudid Primary ID: 6146

Provox Life LP Kit 17 - LT 10/55-2HTTP (UDI 6146)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Provox Life LP Kit 17 - LT 10/55-2HTTP (Model/Catalog Number: 6146) is a medical device manufactured by Atos Medical AB. This product is indexed under FDA Product Code / Category Classification OGW within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1548-2021 View Full Alert →

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac...

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Technical Specifications

Model Number: 6146
Product Code / EMDN: OGW
Device Name: Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) approved for 24-hour use.These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent):Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Database Sync Date: 2026-08-09 09:10:28

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 Provox Life LP Kit 17 - LT 10/55-2HTTP?

The registered manufacturer of record for Provox Life LP Kit 17 - LT 10/55-2HTTP is Atos Medical AB.

What is the Primary UDI-DI identifier for Provox Life LP Kit 17 - LT 10/55-2HTTP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6146.

What classification code is assigned to this device?

This device is registered under product classification code OGW.

Similar Classification Devices (OGW)

Other Devices by Atos Medical AB

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