Amerishield

GUDID 00860004941910

Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Inner Carton of 50 Masks, K211520

Premiumestore, LLC

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

• Primary Device ID: 00860004941910
• NIH Device Record Key: 7e4efee7-10a3-4ee8-abaf-e893975bbe74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amerishield
• Version Model Number: PPE-M-AS-SUR-LVL2-S
• Company DUNS: 014851503
• Company Name: Premiumestore, 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: 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: false

Customer Support Contacts

• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com
• Phone: 888-267-1801
• Email: support@premium-ppe.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in indoor conditions. Avoid heat, light, and excessive humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004941910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211520

FDA Product Code

• FXX: Mask, Surgical

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: 2022-07-04
• Device Publish Date: 2022-06-24

On-Brand Devices [Amerishield]

• 10860004941924: Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Outer Case of 2,0
• 00860004941927: Premium-PPE Amerishield AirMax Procedure Mask, ASTM Level 3, 4-Ply Adult Blue, Inner Carton of 5
• 10860004941917: Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Outer Case of 2,000 Masks
• 00860004941910: Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Inner Carton of 50 Masks,