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Provox Life LaryTube 9/55 Fenestrated

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Life LaryTube 9/55 Fenestrated 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. Fenestrated model – made for voice prosthesis users. Can be attached with a Provox TubeHolder or Provox LaryClips. FDA UDI
Model / Reference
7432 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. Fenestrated model – made for voice prosthesis users. Can be attached with a Provox TubeHolder or Provox LaryClips. FDA UDI

Identifiers

Catalog Number
7432 FDA UDI
Primary DI / UDI-DI
07331791013737 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 — 10.5 Millimeter FDA UDI
Outer Diameter — 13.5 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

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

Provox Life LaryTube 9/55 Fenestrated 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 c71ce967-b654-4e9e-9f55-f90d61754263 37 fields · synced Jun 1, 2026