Provox FreeHands Support

Basic Information

• Brand Name: Provox FreeHands Support
• Primary DI: 07331791009280
• Version / Model: Medium
• Catalog Number: 8022
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-12
• Public Version: 1
• Public Version Date: 2022-07-20
• Public Version Status: New
• Public Device Record Key: 214d30cf-7cb6-4ed2-acab-a9d354664ec8

Device Description

Provox FreeHands Support provides support to the Provox adhesive when using a Provox hands-free speaking valve after total laryngectomy. The device is a single patient use device with a single use adhesive. The reusable Provox FreeHands Support is available in three different variants; ‘Flat’, ‘Medium’ and ‘Deep’. The three variants, as well as the possibility to adjust the metal ring and plastic parts, enable personal fit.

Device Characteristics

• Single Use: No
• 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
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62155	Tracheostomy base plate, reusable	A non-sterile flexible device designed to adhere to the skin around a tracheostoma to function as an anchor for a tracheostomal device (e.g., shower shield, hands-free speech valve). It is made of synthetic polymer and/or metal materials and is available in various forms (e.g., an annular disc with a slightly protruding hollow centre designed to accept the intended device, or a ring on a vertical support); it may include an adhesive backing or be intended to adhere with a separate medical adhesive or tape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791009280	GS1

Customer Contacts

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

Storage Conditions

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