Freevent DualCare Speaking Valve Blue (UDI 7755)
Manufactured by Atos Medical AB
Device Regulatory Overview
The Freevent DualCare Speaking Valve Blue (Model/Catalog Number: 7755) is a medical device manufactured by Atos Medical AB. This product is indexed under FDA Product Code / Category Classification JOH 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
- 7755
- Product Code / EMDN
- JOH
- Device Name
- Freevent DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the speaking valve into speaking mode air is re-directed to enable speech.
- 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 Freevent DualCare Speaking Valve Blue?
The registered manufacturer of record for Freevent DualCare Speaking Valve Blue is Atos Medical AB.
What is the Primary UDI-DI identifier for Freevent DualCare Speaking Valve Blue?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7755.
What classification code is assigned to this device?
This device is registered under product classification code JOH.
Similar Classification Devices (JOH)
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