United Sewing Automation

GUDID 00850018322003

High Fluid Resistant Surgical Face Masks

United Sewing Automation, Inc.

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

• Primary Device ID: 00850018322003
• NIH Device Record Key: 395c5350-428c-44e3-b1de-9f05dd2ec8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Sewing Automation
• Version Model Number: U-325W
• Company DUNS: 050795583
• Company Name: United Sewing Automation, Inc.
• 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: false
• 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: true

Customer Support Contacts

• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com
• Phone: 3364154591
• Email: Info@unitedsewinginc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018322003 [Primary]
GS1	00850018322126 [Package]; Package: Case Pack [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202697

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: 2022-11-21
• Device Publish Date: 2022-11-11