I-Portal Portable Assessment System IPAS

GUDID B290IPAS0

Nystagmograph

N K I

Caloric vestibular-stimulation system Caloric vestibular-stimulation system

• Primary Device ID: B290IPAS0
• NIH Device Record Key: 8f9cc3df-6795-4670-a2b9-dffe18e10291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-Portal Portable Assessment System
• Version Model Number: IPAS
• Catalog Number: IPAS
• Company DUNS: 151391174
• Company Name: N K I
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B290IPAS0 [Primary]

FDA Product Code

• GWN: Nystagmograph

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: 2018-06-15
• Device Publish Date: 2018-05-15

Devices Manufactured by N K I

• B290NOTC0 - Neuro Kinetics Inc: 2020-01-06 Nystagmograph
• B290SVNG0 - I-Portal Super VNG: 2020-01-06 Video-Nystagmograph
• B290SVNG1 - I-Portal Super VNG: 2018-07-06 Video-Nystagmograph
• B290IPAS0 - I-Portal Portable Assessment System: 2018-06-15Nystagmograph
• B290IPAS0 - I-Portal Portable Assessment System: 2018-06-15 Nystagmograph