Matrix Wearable 009-400-0192

GUDID 00815187020563

M5 Recorder, USB Cable, USB Charger, Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cable (1-Meter)

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: 00815187020563
• NIH Device Record Key: ae300ad5-4263-41c0-89ff-0c90c599d1e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix Wearable
• Version Model Number: 009-400-0192
• Catalog Number: 009-400-0192
• Company DUNS: 147035427
• Company Name: GLOBAL INSTRUMENTATION, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815187020563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202456

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-19
• Device Publish Date: 2021-03-11

On-Brand Devices [Matrix Wearable]

• 00815187020600: M5 Recorder, 4-Lead Patient Cable (RL lead) AHA Kit 00815187020556; M5 Recorder 00815187020471
• 00815187020563: M5 Recorder, USB Cable, USB Charger, Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cabl
• 00815187020556: M5 Recorder
• 00815187020549: M5 USB Cable (1-Meter)
• 00815187020471: M5 4-Lead Patient Cable - RL (AHA)
• 00815187020433: M5 2-Lead Patch
• 00815187020570: M5 Neck Lanyard
• 00815187020594: M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5
• 00815187020587: M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5
• 00815187020457: M5 3-Lead Patient Cable AHA
• 00815187020440: M5 2-Lead Patient Cable AHA
• 00815187020112: M5 Patient Cable Cradle