CORE 500 Digital Stethoscope - Black Earpiece CAC500_BLK

GUDID 00850010298450

CORE 500 Digital Stethoscope - Black Earpiece

Eko Devices, Inc.

Electronic acoustic stethoscope

• Primary Device ID: 00850010298450
• NIH Device Record Key: 6b63451f-ad54-401a-b10a-4f370a7ae37f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE 500 Digital Stethoscope - Black Earpiece
• Version Model Number: E8
• Catalog Number: CAC500_BLK
• 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	00850010298450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233609

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: 2025-03-20
• Device Publish Date: 2025-03-12

Devices Manufactured by Eko Devices, Inc.

• 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
• 00850010298252 - CORE 500 Digital Stethoscope FIGS Earpiece - Grey: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Grey
• 00850010298269 - CORE 500 Digital Stethoscope FIGS Earpiece - Mauve: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Mauve
• 00850010298276 - CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
• 00850010298306 - CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue
• 00850010298313 - CORE 500 Digital Stethoscope FIGS Earpiece - Moss: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Moss
• 00850010298399 - CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon