GUDIDData
gudid Primary ID: 7769

Freevent O2 Adaptor (10 pcs) (UDI 7769)

Manufactured by Atos Medical AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Freevent O2 Adaptor (10 pcs) - Primary ID 7769

Device Regulatory Overview

The Freevent O2 Adaptor (10 pcs) (Model/Catalog Number: 7769) 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
7769
Product Code / EMDN
BYD
Device Name
Freevent O2 Adaptor and Freevent O2 Adaptor Mini are single use accessories used together with Freevent XtraCare or Freevent XtraCare Mini respectively. The devices are intended to enable additional oxygen supply for patients breathing through a tracheostoma during use of Freevent XtraCare and Freevent XtraCare Mini.
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 Freevent O2 Adaptor (10 pcs)?

The registered manufacturer of record for Freevent O2 Adaptor (10 pcs) is Atos Medical AB.

What is the Primary UDI-DI identifier for Freevent O2 Adaptor (10 pcs)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7769.

What classification code is assigned to this device?

This device is registered under product classification code BYD.

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