Provox Dilator

Basic Information

• Brand Name: Provox Dilator
• Primary DI: 07331791000850
• Version / Model: 7211
• Catalog Number: 7211
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 1
• Public Version Date: 2022-12-01
• Public Version Status: New
• Public Device Record Key: a2e57116-ab19-4c34-8f03-8b17dc2bf1a2

Device Description

The Provox Dilator is intended for upsizing smaller tracheo-esophageal (TE) punctures (i.e. from 16 Fr diameter) to allow fitting of Provox voice prostheses, or upsizing a shrunken puncture to an adequate diameter, i.e. after loss of a voice prosthesis. The dilator may also be used for temporary blockage of a TE puncture or to temporarily prevent such from shrinkage. It is only intended to be used by physicians or speech pathologists/therapists trained in the care and rehabilitation of laryngectomized.

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62125	Tracheoesophageal fistula dilator	A hand-held, manual non-surgical instrument intended to dilate a surgically-created tracheoesophageal fistula (puncture) to facilitate insertion of a tracheoesophageal device (typically a non-indwelling tracheoesophageal speech valve); it may in addition be used as a temporary occluder to prevent leakage of fluids from the oesophagus into the trachea. It is a flexible, tapered, synthetic polymer shaft with a handle designed to access the fistula via the tracheostoma. It is intended for transient-use by the patient or clinician, in the home and healthcare facility. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791000850	GS1

Customer Contacts

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

Storage Conditions

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