HME DigiTop O2 (UDI 7756)
Manufactured by Atos Medical AB
Device Regulatory Overview
The HME DigiTop O2 (Model/Catalog Number: 7756) 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
- 7756
- Product Code / EMDN
- BYD
- Device Name
- The HME DigiTop O2 is an accessory to Freevent HMEs and Provox FreeHands HME's. For patients spontaneously breathing through a tracheostoma and having a need of extra oxygen.
- 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 HME DigiTop O2?
The registered manufacturer of record for HME DigiTop O2 is Atos Medical AB.
What is the Primary UDI-DI identifier for HME DigiTop O2?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7756.
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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