Provox Life LaryTube

Basic Information

• Brand Name: Provox Life LaryTube
• Primary DI: 07331791014949
• Version / Model: 8/36 Fenestrated with ring
• Catalog Number: 8048
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: a64d766f-aee4-4616-b7c5-f76d247f4d7a

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. Fenestrated with Ring model – made for voice prosthesis users. Can only be attached with a Provox Life Adhesive.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAC	Tube, Laryngectomy	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791014949	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	9.5	Millimeter
Outer Diameter	12.0	Millimeter
Length	36	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 108 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 42 Degrees Celsius