Infrascanner 2500

GUDID 00861606000326

Handheld Brain Hematoma Detector

INFRASCAN, INC.

Near-infrared intracranial haematoma detector

• Primary Device ID: 00861606000326
• NIH Device Record Key: 1834d3eb-bcc0-4d57-94c7-cb1f018221d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrascanner
• Version Model Number: 2500
• Catalog Number: 2500
• Company DUNS: 153408179
• Company Name: INFRASCAN, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00861606000326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200203

FDA Product Code

• OPT: Infrared Hematoma Detector

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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [Infrascanner]

• 00861606000302: Handheld Brain Hematoma Detector
• 00861606000326: Handheld Brain Hematoma Detector