ClearMask

GUDID 10860005106025

Box of 24 masks; Note: individual masks are NOT for sale. Intended use: The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.

Clearmask, LLC

Surgical/medical face mask, single-use

• Primary Device ID: 10860005106025
• NIH Device Record Key: 8c176c7d-f577-4bdd-9bbc-295ace2cb365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearMask
• Version Model Number: v1.0
• Company DUNS: 080991401
• Company Name: Clearmask, LLC
• Device Count: 24
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005106028 [Primary]
GS1	00860005106035 [Unit of Use]
GS1	10860005106025 [Package]; Contains: 00860005106028; Package: Case [18 Units]; In Commercial Distribution
GS1	20860005106022 [Package]; Package: Pallet [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200576

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: 2020-11-30
• Device Publish Date: 2020-11-20