gudid Primary ID: Breeze Facial Comfort M

Breeze (UDI Breeze Facial Comfort M)

Manufactured by SEFAM

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Breeze (Model/Catalog Number: Breeze Facial Comfort M) is a medical device manufactured by SEFAM. This product is indexed under FDA Product Code / Category Classification BZD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Breeze Facial Comfort M
Product Code / EMDN: BZD
Device Name: The Breeze Facial Comfort Mask is designed for non invasive ventilation via the use of a barometric device delivering Continuous Positive Airway Pressure (CPAP) or bi-level pressure (BiPAP).
Database Sync Date: 2026-08-09 09:52:14

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 Breeze?

The registered manufacturer of record for Breeze is SEFAM.

What is the Primary UDI-DI identifier for Breeze?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Breeze Facial Comfort M.

What classification code is assigned to this device?

This device is registered under product classification code BZD.

Similar Classification Devices (BZD)

Other Devices by SEFAM

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