USB Response Box

Basic Information

• Brand Name: USB Response Box
• Primary DI: 00817020020327
• Version / Model: M031501
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• Labeler DUNS: 154870455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d3e41204-7e96-4361-9bd9-324ee81d6d2d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61427	Visual-reinforcement-audiometry reward system	An assembly of mains electricity (AC-powered) devices intended to be used in conjunction with an audiometer to reward an infant/child during instrumentation conditioned reflex audiometry/play audiometry. It includes hardware (e.g., monitor, lights) intended to give the child a visual reward, and dedicated operating software; it may include additional controls (e.g., foot-switch) and toys. It is intended to be operated by the healthcare professional to build the conditioned response during auditory testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817020020327	GS1

Premarket Submissions

Submission Number	Supplement Number
K900096	000