Protect U Guard Tie On Face Mask 3 Ply White

GUDID B086100421

PROTECT U GUARD, LLC

Surgical/medical face mask, single-use

• Primary Device ID: B086100421
• NIH Device Record Key: 083d7ff5-6947-4a13-ba73-d92296c0dcb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protect U Guard Tie On Face Mask 3 Ply White
• Version Model Number: P10042
• Company DUNS: 080070945
• Company Name: PROTECT U GUARD, LLC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B086100420 [Unit of Use]
HIBCC	B086100421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153409

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-02-24

On-Brand Devices [Protect U Guard Tie On Face Mask 3 Ply White]

• B086200422: P20042
• B086100421: P10042