Provox Adhesive Remover

Basic Information

• Brand Name: Provox Adhesive Remover
• Primary DI: 07331791009235
• Version / Model: 8012
• Catalog Number: 8012
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-11-24
• Public Version: 1
• Public Version Date: 2022-12-02
• Public Version Status: New
• Public Device Record Key: 44b2fab2-c908-4006-8e4e-f008b1f01921

Device Description

Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue.

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
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07331791016370	GS1
Primary	07331791009235	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