Sanitas™ Clinical Care Platform

GUDID 00860508000311

The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.

SANITAS, INC.

Self-care monitoring/reporting software

• Primary Device ID: 00860508000311
• NIH Device Record Key: 57fc97fd-eab9-4f63-8d17-71727c523312
• Commercial Distribution Discontinuation: 2020-01-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sanitas™ Clinical Care Platform
• Version Model Number: Version 3.0 Released 20160615
• Company DUNS: 968618426
• Company Name: SANITAS, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: (877) 504-6575
• Email: support@sanitasinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860508000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123671

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: 4
• Public Version Date: 2020-01-28
• Device Publish Date: 2016-08-01

Devices Manufactured by SANITAS, INC.

• 00860508000304 - Family Healthware™: 2020-01-28 Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six
• 00860508000311 - Sanitas™ Clinical Care Platform: 2020-01-28The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
• 00860508000311 - Sanitas™ Clinical Care Platform: 2020-01-28 The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and