RhythmStar

GUDID 00868282000206

RHYTHMEDIX, LLC

Electrocardiography telemetric monitoring system

• Primary Device ID: 00868282000206
• NIH Device Record Key: ed2a45a3-65fb-4440-826b-ad7d162f7502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RhythmStar
• Version Model Number: RS-10002
• Company DUNS: 058907377
• Company Name: RHYTHMEDIX, 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: 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: (856) 282-1080
• Email: info@rhythmedix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868282000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141813

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

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: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [RhythmStar]

• 00868282000213: RS-10002V
• 00868282000206: RS-10002
• 00868282000220: RS-10003