Moldex Airwave Surgical N95 Respirator

GUDID 50092311415005

MOLDEX-METRIC, INC.

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 50092311415005
• NIH Device Record Key: 3da5115a-b3de-4352-a6cb-670659dfda2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moldex Airwave Surgical N95 Respirator
• Version Model Number: 4150
• Company DUNS: 066237736
• Company Name: MOLDEX-METRIC, INC.
• Device Count: 8
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092311415000 [Primary]
GS1	10092311415007 [Unit of Use]
GS1	50092311415005 [Package]; Contains: 00092311415000; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• MSH: Respirator, 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: 2022-03-07
• Device Publish Date: 2022-02-25

Devices Manufactured by MOLDEX-METRIC, INC.

• 50092311415005 - Moldex Airwave Surgical N95 Respirator: 2022-03-07
• 50092311415005 - Moldex Airwave Surgical N95 Respirator: 2022-03-07
• 00092311151007 - Moldex: 2020-05-06
• 50092311151101 - Moldex: 2020-05-06
• 50092311151200 - Moldex: 2020-05-06
• 00092311151304 - Moldex: 2020-05-06
• 5092311151705 - Moldex: 2020-05-06
• 50092311171208 - Moldex: 2020-05-06
• 00092311221007 - Moldex: 2020-05-06