Provox Brush Long

Basic Information

• Brand Name: Provox Brush Long
• Primary DI: 07331791015588
• Version / Model: 8404
• Catalog Number: 8404
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 2
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: aa57479f-d7b4-4b1c-a663-96302161e18b

Device Description

Provox Brush is a single patient use device intended for cleaning Provox voice prostheses, for insertion of Provox Plug and Provox Vega Plug, for applying lubricant and anti-candida agents and for cleaning of fenestration holes on Provox LaryTubes. The product is intended for use by the patient.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62095	Airway device cleaning utensil, invasive	A non-sterile hand-held device intended to be used to clean an in situ airway device (e.g., indwelling tracheoesophageal speech valve, laryngeal airway). It is inserted into the central lumen of the device and typically rotated multiple times to remove organic matter (e.g., phlegm); it may also be used to clean an airway device ex situ (i.e., once it has been removed from the patient). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07331791016790	GS1
Primary	07331791015588	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