FDA.reportPublic FDA data

Provox Life LaryTube 10/36 Standard

Primary DI
07331791013911
Brand
Provox Life LaryTube 10/36 Standard
Company
Atos Medical AB
Model
7416
Catalog number
7416
Device 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 model – made for use with or without a voice prosthesis. Can be attached with a Provox TubeHolder or Provox LaryClips.
Published
2022-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KACTube, Laryngectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791013911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791013911073317910139117331791013911

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length36Millimeter
Lumen/Inner Diameter12Millimeter
Outer Diameter15Millimeter

Storage And Handling#

Type, Low, High table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags#

DUNS number
355470923
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331791001611Provox Adhesive FlexiDerm Round725372532022-07-13
07331791001628Provox Adhesive FlexiDerm Oval725472542022-07-13
07331791001635Provox Adhesive OptiDerm Round725572552022-07-13
07331791001642Provox Adhesive OptiDerm Oval725672562022-07-13
07331791001703Provox XtraBase Adhesive726572652022-07-13
07331791008016Provox StabiliBase (15 pcs)728972892022-07-13
07331791008160Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791008177Provox Adhesive OptiDerm Plus733273322022-07-13
07331791009037Provox StabiliBase OptiDerm (15 pcs)731873182022-07-13
07331791009259Provox Luna Adhesive801480142022-07-13
07331791009303Provox FreeHands Support Adhesive (15 pcs)802480242022-07-13
07331791009525Provox Adhesive Strip801580152022-07-13
07331791014420Provox Life Standard Adhesive Round746074602022-07-13
07331791014437Provox Life Standard Adhesive Oval746174612022-07-13
07331791014444Provox Life Standard Adhesive Plus746274622022-07-13
07331791014451Provox Life Sensitive Adhesive Round746374632022-07-13
07331791014468Provox Life Sensitive Adhesive Oval746474642022-07-13
07331791014475Provox Life Sensitive Adhesive Oval B746574652022-07-13
07331791014482Provox Life Sensitive Adhesive Plus746674662022-07-13
07331791014499Provox Life Stability Adhesive826382632022-07-13

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Primary DI, Brand, Company table
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