Provox® NID™

Basic Information

• Brand Name: Provox® NID™
• Primary DI: 07331791000362
• Version / Model: 20 Fr
• Catalog Number: 7114
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e23bec15-3dfa-4753-be18-d323a1a4c4a7

Device Description

Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	874.3730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44412	Tracheoesophageal speech valve, non-indwelling	A non-sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy, following wound healing, to provide the patient with voice restoration. It is placed by the trained patient into the fistula. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The user removes this device periodically for cleaning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791000362	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043138	000

Device Sizes

Type	Value	Unit	Text
Length	12	Millimeter

Storage Conditions

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