Eko App Windows

GUDID 00863609000358

Windows PC Application for use with Eko products.

EKO DEVICES, INC.

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• Primary Device ID: 00863609000358
• NIH Device Record Key: 9e7c0a88-0c68-4a22-bc19-a34825397c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eko App Windows
• Version Model Number: 1.2.4
• Company DUNS: 079670921
• Company Name: EKO DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00863609000358 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-08-16

Devices Manufactured by EKO DEVICES, INC.

• 00850010298160 - Eko CORE 500 Digital Stethoscope Chestpiece: 2023-07-18 Eko CORE 500 Digital Stethoscope Chestpiece
• 00850010298177 - Eko CORE 500 Digital Stethoscope Earpiece: 2023-07-18
• 00850010298191 - Eko CORE 500 and CAC500 Standard bundle: 2023-07-18 Eko CORE 500 and CAC500 Standard bundle
• 00850010298207 - Eko CORE 500 and CAC500 Founder's Edition bundle: 2023-07-18
• 00850010298214 - Eko CORE 500 Founder's Edition Chestpiece: 2023-07-18 Eko CORE 500 Founder's Edition Chestpiece
• 00850010298061 - Eko Mobile App Android International: 2021-04-20 Eko mobile app for android international platforms for use with Eko medical devices.
• 00850010298030 - Eko Analysis Software: 2020-09-16 The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’
• 00850010298009 - Eko Core Digital Attachment: 2020-05-08 The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tub