FDA.report

Provox LaryTube

Primary DI
07331791002274
Brand
Provox LaryTube
Company
Atos Medical AB
Model
12/36
Catalog number
7614
Device description
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Published
2022-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KACTube, Laryngectomy

Product Code Classifications

CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07331791002274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07331791002274073317910022747331791002274

GMDN Terms

TermDefinition
Tracheostomy tube, non-reinforced, non-customized, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Device Sizes

TypeValueUnit
Length36Millimeter
Lumen/Inner Diameter13.5Millimeter
Outer Diameter17Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags

DUNS number
355470923
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07331791181238Provox Life Comfort Adhesive Oval840384032026-01-16
07331791181276Provox Life Comfort Experience Oval809480942026-01-16
07331791181153Provox Life Oxygen (10 pcs)762076202025-12-16
07331791181160Provox Life Oxygen (30 pcs)762176212025-12-16
07331791181177Provox Dilator 17834283422025-07-01
07331791181184Provox Dilator 20834383432025-07-01
07331791181191Provox Dilator834183412025-02-08
07331791016905Provox Adhesive OptiDerm Round725572552022-07-13
07331791016929Provox XtraBase Adhesive726572652022-07-13
07331791016899Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791016912Provox Adhesive OptiDerm Plus733273322022-07-13
07331791016943Provox Life Go HME831083102022-12-07
07331791016950Provox Life Home HME831183112022-12-07
07331791016967Provox Life Energy HME831283122022-12-07
07331791016974Provox Life Protect HME831383132022-12-07
07331791017124Freevent XtraCare Mini Blue (30 pcs)800580052023-12-04
07331791017131Freevent XtraCare Mini Pink (30 pcs)800680062023-12-04
07331791017148Freevent XtraCare Mini White (5 pcs)800880082023-12-04
07331791017155Freevent O2 Adaptor Mini (10 pcs)800780072023-12-04
07331791017001Provox Life Standard Experience Round806580652022-11-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08904428747900OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747917OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747924OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747931OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747948OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747955OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428748006OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428748013OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314533OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314519OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314496OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314465OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314441OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314427OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314403OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314380OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428750634OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750641OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750658OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750665OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750672OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750689OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750696OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750702OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039311716OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039315202OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10