C.O. Accessories

GUDID 06944413838963

Edan Instruments, Inc.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 06944413838963
• NIH Device Record Key: 5012e95b-3c3d-4497-97fb-6acdb56797dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C.O. Accessories
• Version Model Number: Connection cable
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413838963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250179

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2025-09-22
• Device Publish Date: 2025-09-14

Devices Manufactured by Edan Instruments, Inc.

• 06944413804197 - ECG Cable: 2025-09-22
• 06944413815704 - ECG Cable: 2025-09-22
• 06944413815711 - ECG Cable: 2025-09-22
• 06944413815728 - ECG Cable: 2025-09-22
• 06944413815735 - ECG Cable: 2025-09-22
• 06944413815742 - ECG Cable: 2025-09-22
• 06944413838963 - C.O. Accessories: 2025-09-22
• 06944413838963 - C.O. Accessories: 2025-09-22
• 06944413838406 - Patient Monitor: 2025-09-15