myPatch® mpE3s

GUDID 00857522005095

2/3 channel myPatch® electrode

DMS-SERVICE LLC

Electrocardiographic electrode, single-use

• Primary Device ID: 00857522005095
• NIH Device Record Key: 91a6e2e9-ded2-423b-b004-82b43142cdd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myPatch®
• Version Model Number: 3 channel
• Catalog Number: mpE3s
• Company DUNS: 824740059
• Company Name: DMS-SERVICE LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)407-2824
• Email: sales@dms-service.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857522005095 [Primary]
GS1	20857522005099 [Unit of Use]

FDA Product Code

• DRX: Electrode, electrocardiograph

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: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [myPatch®]

• 00857522005095: 2/3 channel myPatch® electrode
• 00857522005019: 3 channel Holter recorder