GERSON 081730

GUDID 00044585917308

1730 Type N95 Particulate Respirator and Surgical Respirator

LOUIS M. GERSON CO.

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

• Primary Device ID: 00044585917308
• NIH Device Record Key: 2e99366d-ac72-4660-8242-33f6605d7f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GERSON
• Version Model Number: 1730
• Catalog Number: 081730
• Company DUNS: 001000363
• Company Name: LOUIS M. GERSON CO.
• Device Count: 20
• DM Exempt: true
• 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: 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	00044585817301 [Unit of Use]
GS1	00044585917308 [Primary]
GS1	00860006025724 [Unit of Use]
GS1	50044585917303 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061375

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: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-01-03

On-Brand Devices [GERSON]

• 00860006025762: Surgical N95 Respirator
• 00044585917308: 1730 Type N95 Particulate Respirator and Surgical Respirator
• 00044585833301: Surgical N95 Respirator