Smartview

GUDID 10789594000913

YOUNG MICROBRUSH, LLC

General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 10789594000913
• NIH Device Record Key: fee39db7-92f5-40fe-b787-fba79f617a7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smartview
• Version Model Number: 291807
• Company DUNS: 929236305
• Company Name: YOUNG MICROBRUSH, 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: 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	00789594000916 [Primary]
GS1	10789594000913 [Package]; Contains: 00789594000916; Package: [3 Units]; In Commercial Distribution
GS1	20789594000910 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• DZN: INSTRUMENTS, DENTAL HAND

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: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by YOUNG MICROBRUSH, LLC

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• 10789594001002 - Microbrush: 2022-08-24 Microbrush Test Swabs, 100mm breakpoint
• 10789594001088 - Microbrush: 2022-08-24 Microbrush Nasopharyngeal Test Swabs, 100mm breakpoint
• 10789594001095 - Microbrush: 2022-08-24 Microbrush Nasopharyngeal Test Swabs, 80mm breakpoint
• 10789594001101 - Microbrush: 2022-08-24 Microbrush Anterior Nares Mid-Turbinate Test Swabs
• 10789594001354 - Microbrush: 2022-08-24 Microbrush Anterior Nares Mid-Turbinate Blue Test Swabs 2.8'' (70mm)
• 10789594001361 - Microbrush: 2022-08-24 Microbrush Anterior Nares Mid-Turbinate White Test Swabs 2.8'' (70mm)