Freevent DualCare Set 15

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 7741

by Atos Medical Inc.

Identity

Trade Name: Freevent DualCare Set 15 EUDAMEDFDA UDI
Generic Name: Tracheostomy tube speech valve FDA UDI
Device Name: Freevent DualCare EUDAMED
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. FDA UDI
Model / Reference: 7741 EUDAMEDFDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 7741 FDA UDI
Primary DI / UDI-DI: 07331791015021 EUDAMEDFDA UDI
Basic UDI-DI: 7331791-HME-0-000-0005-XQ EUDAMED
510(k) Number: K151404 FDA UDI
FDA Product Code: JOH FDA UDI
EMDN Code: R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
GMDN Term: Tracheostomy tube speech valve FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 868.5800 FDA UDI
Market of Registration: Austria EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 15 Millimeter FDA UDI

Category: Tracheostomy tube speech valve

Freevent DualCare Set 15 by Atos Medical Inc. — Class II — 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-CA007-02) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
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

Cleared under the same submission

K151404 also covers:

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 II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Atos Medical Inc.

Sources (2)

FDA UDI 8a97d197-4f48-4e9b-b6aa-1b067c88be99 38 fields · synced Sep 18, 2026
EUDAMED 1d4d91a5-991a-499a-ae6c-4afa103bf8af 61 fields · synced Sep 18, 2026