Eko CORE 500 and CAC500 Standard bundle COR501

GUDID 00850010298191

Eko CORE 500 and CAC500 Standard bundle

Eko Devices, Inc.

Electronic stethoscope

• Primary Device ID: 00850010298191
• NIH Device Record Key: bd8f96fc-ce9e-4217-9daf-ad19e84beaef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eko CORE 500 and CAC500 Standard bundle
• Version Model Number: COR501
• Catalog Number: COR501
• Company DUNS: 079670921
• Company Name: Eko Devices, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00850010298191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230111

FDA Product Code

• DQD: Stethoscope, Electronic

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: 2023-07-18
• Device Publish Date: 2023-07-10

Devices Manufactured by Eko Devices, Inc.

• 00850010298726 - CORE 500 Digital Stethoscope - Electric Pink Chestpiece: 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Chestpiece
• 00850010298757 - CORE 500 Digital Stethoscope - Electric Pink Earpiece: 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Earpiece
• 00850010298788 - CORE 500 Digital Stethoscope - Bundle-SLV: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-SLV
• 00850010298795 - CORE 500 Digital Stethoscope - Bundle-BLK: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-BLK
• 00850010298801 - CORE 500 Digital Stethoscope - Bundle-CHP: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-CHP
• 00850010298818 - CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink: 2025-08-20 CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink
• 00850010298733 - CORE 500 Digital Stethoscope - Ruby Earpiece: 2025-03-27 CORE 500 Digital Stethoscope - Ruby Earpiece
• 00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black