Provox Life FreeHands HME (UDI 7440)
Manufactured by Atos Medical AB
Device Regulatory Overview
The Provox Life FreeHands HME (Model/Catalog Number: 7440) 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.
Enforcement actions are currently active for this product line.
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac...
Technical Specifications
- Model Number
- 7440
- Product Code / EMDN
- BYD
- Device Name
- Provox Life FreeHands HME is a single use heat- and moisture exchanger intended for spontaneously breathing laryngectomized patients, utilizing a voice prosthesis and in combination with a Provox speaking valve.
- 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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Provox Life FreeHands HME?
The registered manufacturer of record for Provox Life FreeHands HME is Atos Medical AB.
What is the Primary UDI-DI identifier for Provox Life FreeHands HME?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7440.
What classification code is assigned to this device?
This device is registered under product classification code BYD.
Similar Classification Devices (BYD)
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