Identity
- Trade Name
- Freevent Connection strap EUDAMEDFDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- Freevent DualCare EUDAMEDFreevent Connection Strap is a clip with a string that is used to secure Freevent DualCare to the patient’s neckband. FDA UDI
- Model / Reference
- 7746 EUDAMEDFDA UDI
- Description
- Freevent Connection Strap is a clip with a string that is used to secure Freevent DualCare to the patient’s neckband. FDA UDI
Identifiers
- Catalog Number
- 7746 FDA UDI
- Primary DI / UDI-DI
- 07331791008238 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-HME-0-000-0005-XQ EUDAMED
- Unit of Use DI
- 07331791016530 EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheostomy tube speech valve
Freevent Connection strap by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube speech valve.
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- nonventilatory nebulizer(atomizer)(JR-CA007-03) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- InHealth Technologies; Blom-Singer® — FREUDENBERG MEDICAL, LLC · Class II
- Montgomery® Tracheostomy Speaking Valve — Boston Medical Products, Inc. · Class II
- Connector — VADI Medical Technology Co., Ltd. · Class IIb
- Humidification Chamber, Infant — BESMED HEALTH BUSINESS CORP. · Class IIa
- Patient Interfaces（Nasal Cannula） — Shenzhen Lifotronic Technology Co., Ltd. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 1b97364c-45e7-47fc-84e7-8e70476de25f 36 fields · synced Jul 14, 2026
- EUDAMED 38d7c521-1c26-4032-baa5-398c525abbf6 61 fields · synced Jul 14, 2026