T3 Risk Analytics Platform

GUDID 00863061000309

T3 Risk Analytics Platform

ETIOMETRY INC.

Multiple-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00863061000309
• NIH Device Record Key: fd086715-c4b6-4c75-bb02-b8d0a24e6107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T3 Risk Analytics Platform
• Version Model Number: 2
• Company DUNS: 961840241
• Company Name: ETIOMETRY 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: 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: false

Customer Support Contacts

• Phone: 8573669333
• Email: support@etiometry.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863061000309 [Primary]

FDA Product Code

• PLB: Multivariate Vital Signs Index

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: 2020-02-06
• Device Publish Date: 2016-09-09