myPatch® mp3

GUDID 00857522005019

3 channel Holter recorder

DMS-SERVICE LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: 00857522005019
• NIH Device Record Key: 1d5c2b32-d422-42ff-9bef-47f2591b7ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myPatch®
• Version Model Number: s
• Catalog Number: mp3
• Company DUNS: 824740059
• Company Name: DMS-SERVICE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Width: 49 Millimeter
• Width: 49 Millimeter
• Width: 49 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857522005019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160704

FDA Product Code

• DSH: RECORDER, MAGNETIC TAPE, MEDICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-16

On-Brand Devices [myPatch®]

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