Face Mask

GUDID 30851253007916

ULINE, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 30851253007916
• NIH Device Record Key: c496168d-c71c-4c1c-a696-bde236e8d007
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Mask
• Version Model Number: S-10478-S1
• Company DUNS: 039612668
• Company Name: ULINE, INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851253007915 [Unit of Use]
GS1	10851253007912 [Primary]
GS1	30851253007916 [Package]; Contains: 10851253007912; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123787

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: 2020-05-06
• Device Publish Date: 2020-03-09

Devices Manufactured by ULINE, INC.

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• 30850015055516 - ULINE REUSABLE EARPLUGS - CORDED: 2024-08-02
• 30850015055523 - ULINE BULLET EARPLUGS - UNCORDED: 2024-07-31
• 30850015055530 - ULINE BULLET EARPLUGS - CORDED: 2024-07-31
• 30850015055547 - ULINE BELL EARPLUGS - UNCORDED: 2024-07-31
• 30850015055554 - ULINE BELL EARPLUGS - CORDED: 2024-07-31
• 30850015055493 - ULINE BULLET EARPLUGS REFILL: 2024-05-21
• 00850015055713 - ULINE EARPLUGS IN A BUCKET: 2024-05-21