Provox Luna HME (30 pcs) (UDI 8013)
Manufactured by Atos Medical AB
Device Regulatory Overview
The Provox Luna HME (30 pcs) (Model/Catalog Number: 8013) 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
- 8013
- Product Code / EMDN
- BYD
- Device Name
- The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use 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 Luna HME (30 pcs)?
The registered manufacturer of record for Provox Luna HME (30 pcs) is Atos Medical AB.
What is the Primary UDI-DI identifier for Provox Luna HME (30 pcs)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8013.
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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