Zywie RX93030-011

GUDID 00851074007378

ECG recorder

DATRIX LLC

Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 00851074007378
• NIH Device Record Key: b920c3db-338b-4e31-84e9-0c72a541bec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zywie
• Version Model Number: Sirona
• Catalog Number: RX93030-011
• 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	00851074007378 [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: 2018-12-07

Devices Manufactured by DATRIX LLC

• 00851074007385 - CardioLabs: 2019-11-08 ECG Recorder (Event)
• 00851074007392 - TLC Diagnostics: 2019-11-08 ECG recorder
• 00851074007361 - Datrix: 2019-11-08 ECG Recorder
• 00851074007002 - Sirona: 2019-11-08 ECG Recorder
• 00851074007019 - VX3+: 2019-11-08 Holter Recorder
• 00851074007026 - VX3+: 2019-11-08 Holter Recorder
• 00851074007033 - BodyGuardian: 2019-11-08 Holter Recorder
• 00851074007040 - CardioHolter: 2019-11-08 Holter Recorder