ECG App

GUDID 00190198909541

APPLE INC.

Cardiac electrophysiology application software

• Primary Device ID: 00190198909541
• NIH Device Record Key: 44bd3e74-b8f9-4d96-9e1f-0019810de75b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG App
• Version Model Number: Feature Version 1.x
• Company DUNS: 060704780
• Company Name: APPLE INC.
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190198909541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN180044

FDA Product Code

• QDA: Electrocardiograph Software For Over-The-Counter Use

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: 2019-02-14
• Device Publish Date: 2019-01-14

On-Brand Devices [ECG App]

• 00190198909541: Feature Version 1.x
• 00190198909534: Feature Version 1.x