NEIL MEDICAL FM1010

GUDID 00850063139250

Disposable Face Mask Level 1

Neil Medical Group

Surgical/medical face mask, non-antimicrobial, reusable

• Primary Device ID: 00850063139250
• NIH Device Record Key: 90c7418f-de0e-4e02-9f36-c2966f1c2b2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEIL MEDICAL
• Version Model Number: FM1010
• Catalog Number: FM1010
• Company DUNS: 122260045
• Company Name: Neil Medical Group
• Device Count: 50
• 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: true
• 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	00850063139250 [Package]; Contains: 00850063139267; Package: [40 Units]; In Commercial Distribution
GS1	00850063139267 [Primary]
GS1	85006313926700 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202708

FDA Product Code

• FXX: Mask, 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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [NEIL MEDICAL]

• 00850063139236: Disposable Nitrile Powder free Examination Gloves
• 00850063139229: Disposable Nitrile Powder free Examination Gloves
• 00850063139212: Disposable Nitrile Powder free Examination Gloves
• 00850063139205: Disposable Nitrile Powder free Examination Gloves
• 00850063139151: Stretch Vinyl Powder free Examination gloves
• 00850063139144: Stretch Vinyl Powder free Examination gloves
• 00850063139137: Stretch Vinyl Powder free Examination gloves
• 00850063139120: Stretch Vinyl Powder free Examination gloves
• 85006313932800: Personal Tripple Blade Razor
• 85006313931100: Isolation Blue Gown
• 00850063139274: Pulse Oximeter
• 00850063139250: Disposable Face Mask Level 1
• 00850063139076: Vinyl Examination Glove Extra Large
• 00850063139069: Vinyl Examination Glove Large
• 00850063139052: Vinyl Examination Glove Medium
• 00850063139007: Vinyl Examination Glove Small