ProTrach® DualCare™ Set 15

FDA UDI

Class II (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name: ProTrach® DualCare™ Set 15 FDA UDI
Generic Name: Tracheostomy tube speech valve FDA UDI
Device Name: ProTrach 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 FDA UDI
Description: ProTrach 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

Primary DI / UDI-DI: 07331791008191 FDA UDI
510(k) Number: K151404 FDA UDI
FDA Product Code: JOH FDA UDI
GMDN Term: Tracheostomy tube speech valve FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 15 Millimeter FDA UDI

ProTrach® DualCare™ Set 15 by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151404 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Atos Medical Inc.

Sources (1)

FDA UDI ceaca718-fce8-46b0-8e95-2dcd7cb9363b 38 fields · synced May 31, 2026