Face Mask

GUDID 00850019294026

Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.

Premier Guard Usa, LLC

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

• Primary Device ID: 00850019294026
• NIH Device Record Key: fa61d59a-e22f-45e1-ba04-10c08bfb134d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Mask
• Version Model Number: 20-1001-FM
• Company DUNS: 117537165
• Company Name: Premier Guard Usa, LLC
• Device Count: 1
• 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: false
• 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	00850019294026 [Primary]

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: 2
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-04-22

Devices Manufactured by Premier Guard Usa, LLC

• 00850019294019 - ASTM Level 3 Surgical Face Mask: 2022-06-27 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural
• 00850019294026 - Face Mask: 2022-06-27Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.
• 00850019294026 - Face Mask: 2022-06-27 Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.
• 10850019294016 - ASTM Level 3 Surgical Face Mask case: 2022-05-02 Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not
• 20850019294006 - ASTM Level 2 Surgical Face Mask Case: 2022-05-02 Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 2 rating. Made with elastic ear loops that do not
• 00850019294002 - ASTM Level 2 Surgical Face Mask: 2021-12-02 3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural
• 00850019294156 - ASTM LEVEL 3 Surgical Face Mask: 2021-05-18 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural