DUO

GUDID 00863609000327

EKO DEVICES, INC.

Electronic stethoscope

• Primary Device ID: 00863609000327
• NIH Device Record Key: 970b4038-8e07-4c14-8ede-21ac9fec8def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUO
• Version Model Number: E5
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863609000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170874

FDA Product Code

• DPS: Electrocardiograph

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: 2018-08-16
• Device Publish Date: 2018-07-16

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