MedSource Face Mask Not Applicable

GUDID 00816703025901

Face Mask, Padded, Adult, Ambu

MEDSOURCE INTERNATIONAL LLC

Aerosol face mask, rebreathing, single-use

• Primary Device ID: 00816703025901
• NIH Device Record Key: 3bb222c8-5719-452f-a675-f72b1b8f96b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Face Mask
• Version Model Number: MS-21135
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703025901 [Primary]

FDA Product Code

• QKR: Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency

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: 2021-05-21
• Device Publish Date: 2021-05-13

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