CardioLabs RX93030-012

GUDID 00851074007385

ECG Recorder (Event)

DATRIX LLC

Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 00851074007385
• NIH Device Record Key: 96febcda-19a2-4bc3-b9b1-b2d200a3a385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioLabs
• Version Model Number: Sirona
• Catalog Number: RX93030-012
• Company DUNS: 080555401
• Company Name: DATRIX 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 760 480-8874
• Email: tbrewer@datrixmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851074007385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112601

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2019-05-13

On-Brand Devices [CardioLabs]

• 00851074007248: Sirona PC App
• 00851074007224: Sirona Android App
• 00851074007187: ECG Recorder
• 00851074007385: ECG Recorder (Event)