Provox Adhesive

Basic Information

• Brand Name: Provox Adhesive
• Primary DI: 07331791009037
• Version / Model: StabiliBase OptiDerm
• Catalog Number: 7318
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2022-07-13
• Public Version: 3
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 1b92cd4f-233b-4fb0-9177-8a6b929871b5

Device Description

Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.

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 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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62175	Removable ambulatory appliance skin-adherent patch	A patch with a pressure-sensitive adhesive coating designed to be adhered to the skin to temporarily secure/affix a removable patient-worn ambulatory appliance (e.g., tracheostomy base plate, insulin infusion pump) to the body. It is made of synthetic polymer materials [e.g., polyurethane] and is available in various designs (e.g., round, slot, spiral, with a central opening to fit the wearable appliance). It is not intended to adhere an external aesthetic restoration prosthesis (e.g., artificial nose, breast prosthesis) to the skin surface. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07331791016462	GS1
Primary	07331791009037	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