Matrix Wearable 009-400-0171

GUDID 00815187020471

M5 4-Lead Patient Cable - RL (AHA)

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: 00815187020471
• NIH Device Record Key: 76c83d45-aae9-41e5-9c8e-e8868628672b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix Wearable
• Version Model Number: 009-400-0171
• Catalog Number: 009-400-0171
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00815187020471 [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