Provox Life Day & Night Experience Oval (UDI 8061)
Manufactured by Atos Medical AB
Device Regulatory Overview
The Provox Life Day & Night Experience Oval (Model/Catalog Number: 8061) 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
- 8061
- Product Code / EMDN
- BYD
- Device Name
- Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostomaProvox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy
- 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 Day & Night Experience Oval?
The registered manufacturer of record for Provox Life Day & Night Experience Oval is Atos Medical AB.
What is the Primary UDI-DI identifier for Provox Life Day & Night Experience Oval?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8061.
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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