physIQ Personalized Physiology Analytics Engine

GUDID 00860004366263

physIQ Personalized Physiology Analytics Engine

PHYSIQ, INC

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system

• Primary Device ID: 00860004366263
• NIH Device Record Key: bcfaef78-f7c2-4828-8f1b-8786ddc198b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: physIQ Personalized Physiology Analytics Engine
• Version Model Number: 2
• Company DUNS: 079107007
• Company Name: PHYSIQ, 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: 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

Customer Support Contacts

• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com
• Phone: +1 855-869-9054
• Email: support@physIQ.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004366263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142512

FDA Product Code

• PLB: Multivariate Vital Signs Index

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: 2022-01-18
• Device Publish Date: 2022-01-10

Devices Manufactured by PHYSIQ, INC

• 00850023120267 - physIQ Patient Kit: 2022-10-04 physIQ convenience kit including biosensors, mobile hub, and skin preparation materials.
• 00850023120274 - physIQ Patient Kit: 2022-10-04 physIQ convenience kit including biosensors, mobile hub and skin preparation materials.
• 00850023120250 - physIQ Patient Kit: 2022-07-06 physIQ convenience kit including biosensors and skin preparation materials.
• 00850023120243 - physIQ Patient Kit: 2022-06-21 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
• 00850023120236 - physIQ Patient Kit: 2022-05-30 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
• 00850023120212 - physIQ Patient Kit: 2022-04-11 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
• 00850023120229 - physIQ Patient Kit: 2022-04-11 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
• 00850023120205 - physIQ Patient Kit: 2022-03-14 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio