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Provox Life LaryTube 8/36 Standard with Ring

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Life LaryTube 8/36 Standard with Ring FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard with Ring model – made for use with or without a voice prosthesis. Can only be attached with a Provox Life Adhesive. FDA UDI
Model / Reference
7421 FDA UDI
Description
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard with Ring model – made for use with or without a voice prosthesis. Can only be attached with a Provox Life Adhesive. FDA UDI

Identifiers

Catalog Number
7421 FDA UDI
Primary DI / UDI-DI
07331791013966 FDA UDI
FDA Product Code
KAC FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

Dimensions & Sizes

Size
Lumen/Inner Diameter — 9.5 Millimeter FDA UDI
Outer Diameter — 12.0 Millimeter FDA UDI
Length — 36 Millimeter FDA UDI

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

Provox Life LaryTube 8/36 Standard with Ring by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI 15393cf1-4103-4ffd-ab20-77b6e268ebf6 37 fields · synced Jun 1, 2026