Provox Life LaryButton 14/18

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name: Provox Life LaryButton 14/18 FDA UDI
Generic Name: Tracheostoma button FDA UDI
Device Name: Provox Life LaryButton is a single patient use self-retaining holder for Provox Life HMEs and accessories after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox Life LaryButton is intended for single patient use. FDA UDI
Model / Reference: 8043 FDA UDI
Description: Provox Life LaryButton is a single patient use self-retaining holder for Provox Life HMEs and accessories after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox Life LaryButton is intended for single patient use. FDA UDI

Identifiers

Catalog Number: 8043 FDA UDI
Primary DI / UDI-DI: 07331791015120 FDA UDI
FDA Product Code: KAC FDA UDI
GMDN Term: Tracheostoma button FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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: Lumen/Inner Diameter — 11.2 Millimeter FDA UDI
Outer Diameter — 14.0 Millimeter FDA UDI
Length — 18 Millimeter FDA UDI

Category: Tracheostoma button

Provox Life LaryButton 14/18 by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Atos Medical Inc.

Sources (1)

FDA UDI d5c0c755-c399-4eeb-9305-32cb019acf1f 37 fields · synced May 31, 2026