gudid Primary ID: 8229

Provox XtraFlow & XtraMoist HME (5+5pcs) (UDI 8229)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Provox XtraFlow & XtraMoist HME (5+5pcs) (Model/Catalog Number: 8229) is a medical device manufactured by Atos Medical AB. This product is indexed under FDA Product Code / Category Classification BYD 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: 8229
Product Code / EMDN: BYD
Device Name: The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
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 XtraFlow & XtraMoist HME (5+5pcs)?

The registered manufacturer of record for Provox XtraFlow & XtraMoist HME (5+5pcs) is Atos Medical AB.

What is the Primary UDI-DI identifier for Provox XtraFlow & XtraMoist HME (5+5pcs)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8229.

What classification code is assigned to this device?

This device is registered under product classification code BYD.

Similar Classification Devices (BYD)

Other Devices by Atos Medical AB

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