NTRAINER 510NT

GUDID 10885380195556

NTrainer System 2.0 Patient Receiver Tubes (10-pack)

INNARA HEALTH, INC.

Evoked-potential graphic recording system

• Primary Device ID: 10885380195556
• NIH Device Record Key: 97076f46-ad7b-4ee0-af09-9ddd637ec476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NTRAINER
• Version Model Number: 510NT
• Catalog Number: 510NT
• Company DUNS: 809608719
• Company Name: INNARA HEALTH, INC.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	10885380195556 [Unit of Use]
GS1	50885380195554 [Primary]
GS1	50885380195561 [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: 2023-07-11
• Device Publish Date: 2023-07-03

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