Innara Health M00045

GUDID 10860009695259

NICU Soothies, Green (box of 20)

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 Evoked-potential graphic recording system

• Primary Device ID: 10860009695259
• NIH Device Record Key: da4f0228-f593-4074-beb1-2088f6882acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innara Health
• Version Model Number: M00045
• Catalog Number: M00045
• Company DUNS: 809608719
• Company Name: INNARA HEALTH, INC.
• Device Count: 20
• 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	00860009695252 [Primary]
GS1	10860009695259 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-02
• Device Publish Date: 2022-10-27

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