gudid Primary ID: Breeze Facial+ M

Breeze (UDI Breeze Facial+ 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+ 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+ M
Product Code / EMDN: BZD
Device Name: The Breeze Facial + 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+ 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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