GUDIDData
gudid Primary ID: 8006

Freevent XtraCare Mini Pink (30 pcs) (UDI 8006)

Manufactured by Atos Medical AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Freevent XtraCare Mini Pink (30 pcs) - Primary ID 8006

Device Regulatory Overview

The Freevent XtraCare Mini Pink (30 pcs) (Model/Catalog Number: 8006) 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
8006
Product Code / EMDN
BYD
Device Name
Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
Database Sync Date
2026-08-09 09:10:28

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Freevent XtraCare Mini Pink (30 pcs)?

The registered manufacturer of record for Freevent XtraCare Mini Pink (30 pcs) is Atos Medical AB.

What is the Primary UDI-DI identifier for Freevent XtraCare Mini Pink (30 pcs)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8006.

What classification code is assigned to this device?

This device is registered under product classification code BYD.

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