ProGear/Oxafence

GUDID 80852212003715

Antiviral Earloop Mask, ASTM Level 3

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, antimicrobial, single-use

• Primary Device ID: 80852212003715
• NIH Device Record Key: 353e04ca-b93e-400b-9c4a-2ea93acd3401
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGear/Oxafence
• Version Model Number: AV82030
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com
• Phone: 8174272700
• Email: orders@prestigeam.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003719 [Primary]
GS1	20852212003713 [Package]; Contains: 00852212003719; Package: Case [10 Units]; In Commercial Distribution
GS1	80852212003715 [Unit of Use]

FDA Product Code

• OUK: Surgical Mask With Antimicrobial/Antiviral Agent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-10-21

On-Brand Devices [ProGear/Oxafence]

• 80852212003715: Antiviral Earloop Mask, ASTM Level 3
• 30852212003710: Antiviral Earloop Mask, ASTM Level 3