ILR ECG Analyzer IM007

GUDID 03770025266008

Implicity Inc.

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• Primary Device ID: 03770025266008
• NIH Device Record Key: 4169ecbf-8964-4bcd-b7a7-1c8f40ba2979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILR ECG Analyzer
• Version Model Number: V1.1.4
• Catalog Number: IM007
• Company DUNS: 118346169
• Company Name: Implicity Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	03770025266008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210543

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by Implicity Inc.

• 03770025266015 - SignalHF: 2024-04-24
• 03770025266008 - ILR ECG Analyzer: 2024-04-23
• 03770025266008 - ILR ECG Analyzer: 2024-04-23