Patient Cable 001-400-0120

GUDID 90815187020191

M12R, 10 Lead Patient Cable

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: 90815187020191
• NIH Device Record Key: 32e3539f-8eac-4edf-a8df-e8a03c874a1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Cable
• Version Model Number: 001-400-0120
• Catalog Number: 001-400-0120
• 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	90815187020191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051730

FDA Product Code

• MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-21

On-Brand Devices [Patient Cable]

• 90815187020351: 5 Lead Patient Cable, IEC, M3R
• 90815187020238: 7 Lead Patient Cable, IEC, HR100
• 90815187020221: 7 Lead Patient Cable, AHA, HR100
• 90815187020214: 5-Lead Patient Cable, IEC
• 90815187020207: 5-Lead Patient Cable, AHA, HR100
• 90815187020191: M12R, 10 Lead Patient Cable
• 90815187020184: M12R, 10 Lead patient Cable (DIN)
• 90815187020177: M12R, 10 Lead patient Cable (AHA)
• 90815187020160: M3R/M12R, 7 Lead patient Cable
• 90815187020153: M3R/M12R, 7 Lead patient Cable (AHA)
• 90815187020146: 7 Lead Patient Cable, IEC, HR300
• 90815187020139: 7 Lead Patient Cable, AHA, HR300
• 90815187020122: 5 Lead Patient Cable, IEC, HR300
• 90815187020078: Patient Cable 3L IEC
• 90815187020061: Patient Cable 5L IEC
• 90815187020054: Patient Cable 3L AHA
• 90815187020009: Patient Cable 5L AHA