SignalHF

GUDID 03770025266015

Implicity Inc.

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• Primary Device ID: 03770025266015
• NIH Device Record Key: e0425f32-e74a-420b-9f09-bae9699daf19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignalHF
• Version Model Number: V1.0.2
• 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	03770025266015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230842

FDA Product Code

• QNL: Medium-Term Adjunctive Predictive Cardiovascular Indicator

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: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by Implicity Inc.

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