GUDIDData
gudid Primary ID: 6142

Provox Life LP Kit 13 - LT 9/55 (UDI 6142)

Manufactured by Atos Medical AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Provox Life LP Kit 13 - LT 9/55 - Primary ID 6142

Device Regulatory Overview

The Provox Life LP Kit 13 - LT 9/55 (Model/Catalog Number: 6142) 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
6142
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 13 - LT 9/55?

The registered manufacturer of record for Provox Life LP Kit 13 - LT 9/55 is Atos Medical AB.

What is the Primary UDI-DI identifier for Provox Life LP Kit 13 - LT 9/55?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6142.

What classification code is assigned to this device?

This device is registered under product classification code OGW.

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