Provox Skin Barrier

Basic Information

• Brand Name: Provox Skin Barrier
• Primary DI: 07331791009228
• Version / Model: 8011
• Catalog Number: 8011
• 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: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 4c0a3df5-65ed-449b-b8b8-47a6a2911382

Device Description

Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.

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
NEC	Bandage, Liquid, Skin Protectant	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58978	Synthetic-polymer liquid barrier dressing	A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. 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	07331791016363	GS1
Primary	07331791009228	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