Innara Health

Basic Information

• Brand Name: Innara Health
• Primary DI: 00860009695238
• Version / Model: IN-5003
• Catalog Number: IN-5003
• Company Name: INNARA HEALTH, INC.
• Labeler DUNS: 809608719
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-11-03
• Public Version: 3
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: 0046f2e7-f364-4503-b091-835554ac7b98

Device Description

Patient Consumables (box of 10)

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HCC	Device, biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11614	Evoked-potential graphic recording system	An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10860009695235	GS1
Primary	00860009695238	GS1

Premarket Submissions

Submission Number	Supplement Number
K071866	000