FungalBlue

GUDID 00860012465019

A temporary skin/nail-marking pen used by clinicians to outline areas of interest on the nail, including regions they plan to assess or debride during management of suspected onychomycosis.

ToeFX Inc

Skin marking pen, single-use

• Primary Device ID: 00860012465019
• NIH Device Record Key: 27e160ac-7e99-4455-b082-4853cae9c86e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FungalBlue
• Version Model Number: TFX-CTS
• Company DUNS: 202099070
• Company Name: ToeFX Inc
• Device Count: 1
• 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: false
• 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	00860012465019 [Primary]

FDA Product Code

• FZZ: Marker, Skin

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: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by ToeFX Inc

• 00860012465019 - FungalBlue: 2025-12-11A temporary skin/nail-marking pen used by clinicians to outline areas of interest on the nail, including regions they plan to assess or debride during management of suspected onychomycosis.
• 00860012465019 - FungalBlue: 2025-12-11 A temporary skin/nail-marking pen used by clinicians to outline areas of interest on the nail, including regions they plan to as
• 00860012465033 - RedRevive: 2025-12-11
• 00086001245602 - TFX-LT2000 Therapy Light: 2024-11-25 Light therapy device for onychomycosis