Innara Health IN-5000

GUDID 00196852124213

NTrainer System 2.0

INNARA HEALTH, INC.

Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system

• Primary Device ID: 00196852124213
• NIH Device Record Key: 49cfa3d5-16d1-4397-874d-81e2287ce3cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innara Health
• Version Model Number: IN-5000
• Catalog Number: IN-5000
• Company DUNS: 809608719
• Company Name: INNARA HEALTH, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852124213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071866

FDA Product Code

• HCC: Device, biofeedback

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: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [Innara Health]

• 10196852668189: Patient Consumables (box of 10)
• 10196852173638: Handpiece Tubing, NTrainer System 2.0 (Qty 2)
• 00196852125432: Handpiece, NTrainer System 2.0 (Qty 1)
• 00196852124213: NTrainer System 2.0
• 10860009695266: Wee Soothies, Purple (box of 20)
• 10860009695259: NICU Soothies, Green (box of 20)
• 10860009695242: Patient Consumables (box of 20)
• 10860009695235: Patient Consumables (box of 10)
• 10860009695228: Handpiece Tubing, NTrainer System 2.0 (Qty 2)
• 00860009695214: Handpiece, NTrainer System 2.0 (Qty 1)
• 00860009695207: NTrainer System 2.0