CORE 500 Digital Stethoscope - Sapphire Bundle COR501-BLU/BLU

GUDID 00850010298641

CORE 500 Digital Stethoscope - Sapphire Bundle

Eko Devices, Inc.

Electronic acoustic stethoscope

• Primary Device ID: 00850010298641
• NIH Device Record Key: d8469f34-dee7-4166-a25a-9bc248c907cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE 500 Digital Stethoscope - Sapphire Bundle
• Version Model Number: E8
• Catalog Number: COR501-BLU/BLU
• 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: true
• 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	00850010298641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233609

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: 2025-03-25
• Device Publish Date: 2025-03-17

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