ASTM Level 3 Surgical Face Mask

GUDID 00850019294019

3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs

Premier Guard Usa, LLC

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 00850019294019
• NIH Device Record Key: 10f40f95-3d8d-4a07-b349-9ad7f1592554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTM Level 3 Surgical Face Mask
• Version Model Number: 20-1002-SFM3
• Company DUNS: 117537165
• Company Name: Premier Guard Usa, 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: false
• 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

Customer Support Contacts

• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com
• Phone: 888-706-1231
• Email: Glenn.Ferreri@premierguardusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019294019 [Primary]
GS1	00850019294330 [Unit of Use]
GS1	10850019294016 [Package]; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202595

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: 2022-06-27
• Device Publish Date: 2021-05-10

On-Brand Devices [ASTM Level 3 Surgical Face Mask]

• 00850019294156: 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear lo
• 00850019294019: 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear lo