Provox Life LaryTube - Provox Life LaryTube is a single patient use - Atos Medical AB

Duns Number:355470923

Device Description: Provox Life LaryTube is a single patient use device intended to provide attachment for Pro 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.

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More Product Details

Catalog Number

7431

Brand Name

Provox Life LaryTube

Version/Model Number

9/36 Fenestrated

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KAC

Product Code Name

Tube, Laryngectomy

Device Record Status

Public Device Record Key

c1201e4d-55b5-402f-b5fc-0014d71921e2

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATOS MEDICAL AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 119
2 A medical device with a moderate to high risk that requires special controls. 169