CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown

GUDID 94710415369010

MEDTECS (TAIWAN) CORP.

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• Primary Device ID: 94710415369010
• NIH Device Record Key: 54eaad49-8c29-49a6-bb00-d7e5440d3250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
• Version Model Number: IL-4036YKTP-L4
• Company DUNS: 658023890
• Company Name: MEDTECS (TAIWAN) CORP.
• Device Count: 10
• 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: true
• 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	04710415363480 [Primary]
GS1	04710415369017 [Primary]
GS1	94710415369010 [Unit of Use]

FDA Product Code

• FYC: Gown, Isolation, 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: 2023-06-26
• Device Publish Date: 2023-06-17

Devices Manufactured by MEDTECS (TAIWAN) CORP.

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