InTouch Health 20-14393

GUDID 00868772000136

INTOUCH TECHNOLOGIES, INC.

Diagnostic imaging telemedicine system

• Primary Device ID: 00868772000136
• NIH Device Record Key: 08fcb58e-39df-4c97-80ee-b2359ecdeae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTouch Health
• Version Model Number: Xpress Remote Presence System Version 2
• Catalog Number: 20-14393
• Company DUNS: 133033717
• Company Name: INTOUCH TECHNOLOGIES, 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: 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
GS1	00868772000136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120895

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2018-07-06
• Device Publish Date: 2016-12-09

On-Brand Devices [InTouch Health]

• 00868772000181: InTouch Lite 4
• 00868772000174: InTouch Imaging
• 00868772000150: Lite Remote Presence System V2
• 00868772000143: Lite Remote Presence System V3
• 00868772000136: Xpress Remote Presence System Version 2
• 00868772000112: Vantage Remote Presence System
• 00868772000105: Vita Remote Presence System
• 00860000825818: InTouch Lite 4 with Boom