Zooby Face Masks

GUDID 20302732954045

YOUNG DENTAL MANUFACTURING I, LLC

Surgical/medical face mask, single-use

• Primary Device ID: 20302732954045
• NIH Device Record Key: be18ba13-660a-4471-b106-549954ce2091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zooby Face Masks
• Version Model Number: 295404
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10302732954048 [Primary]
GS1	20302732954045 [Package]; Contains: 10302732954048; Package: shipping box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020474

FDA Product Code

• MSH: Respirator,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: 2017-03-16

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