ULINE S-10478

GUDID 10851253007400

Light blue polypropylene Surgical Mask with ear loops and adjustable nose piece.

ULINE, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 10851253007400
• NIH Device Record Key: 826eee69-b349-4dfa-90f5-278bd830da26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULINE
• Version Model Number: S-10478
• Catalog Number: S-10478
• 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	00851253007403 [Unit of Use]
GS1	10851253007400 [Primary]
GS1	30851253007404 [Package]; Package: Carton [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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-23

On-Brand Devices [ULINE]

• 30851253007565: Deluxe Surgical Mask
• 10851253007400: Light blue polypropylene Surgical Mask with ear loops and adjustable nose piece.