HealthView ECG Manager 113-01003

GUDID 00857560008010

The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

LUMEDX CORPORATION

Cardiology information system application software

• Primary Device ID: 00857560008010
• NIH Device Record Key: 2cfe59a1-a2a0-4af7-83ba-4430849c3894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthView ECG Manager
• Version Model Number: 1.2.4
• Catalog Number: 113-01003
• Company DUNS: 625427471
• Company Name: LUMEDX CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857560008010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123466

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-11-30

Devices Manufactured by LUMEDX CORPORATION

• 00857560008003 - HealthView CardioPACS: 2019-12-30 CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and
• 00857560008010 - HealthView ECG Manager: 2019-03-11The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
• 00857560008010 - HealthView ECG Manager: 2019-03-11 The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained profess