CoordiNation Centric TD-3223 Blood Glucose Plus Blood Pressure Monitoring System

GUDID 04713106021461

COORDINATION CENTRIC, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04713106021461
• NIH Device Record Key: 4b3c6d3f-11f3-4857-a342-b2875e8dd91c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoordiNation Centric TD-3223 Blood Glucose Plus Blood Pressure Monitoring System
• Version Model Number: TD-3223
• Company DUNS: 085504617
• Company Name: COORDINATION CENTRIC, LLC
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713106021461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093592

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-11-20