Infrascanner

Basic Information

• Brand Name: Infrascanner
• Primary DI: 00861606000302
• Version / Model: 2000
• Catalog Number: 2000
• Company Name: INFRASCAN, INC.
• Labeler DUNS: 153408179
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 5
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: ff5198c3-c5ab-486a-a85c-affa2122a57b

Device Description

Handheld Brain Hematoma Detector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OPT	Infrared Hematoma Detector	Ophthalmic	882.1935	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62661	Near-infrared intracranial haematoma detector	A noninvasive, hand-held, electrically-powered device intended to be used to scan a patient’s head for the detection of an intracranial (e.g., epidural, subdural and intracerebral) haematoma, using near-infrared (NIR) technology. It consists of a control unit which emits an infrared laser, measures reflection with an optical detector, and displays processed results. Typically, the recorded patient data from the scan can be downloaded from the device for further assessment by a medical professional.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861606000302	GS1

Premarket Submissions

Submission Number	Supplement Number
K120949	000