NTrainer A10002

GUDID 00860000688611

NTrainer System

INNARA HEALTH, INC.

Evoked-potential graphic recording system

• Primary Device ID: 00860000688611
• NIH Device Record Key: c57f6b8c-3154-46c0-afaf-b494b5b619d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NTrainer
• Version Model Number: A10002
• Catalog Number: A10002
• 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	00860000688611 [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: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [NTrainer]

• B184A100020: NTrainer System
• B184A000020: NTrainer System
• 00860000688611: NTrainer System
• 00860000688604: NTrainer System
• 10885380195556: NTrainer System 2.0 Patient Receiver Tubes (10-pack)
• 10885380195587: NTrainer System 2.0