Holter ECG Cable

GUDID 06944413803657

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944413803657
• NIH Device Record Key: 14f8a73f-29ed-4962-8510-377ea707c63b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter ECG Cable
• Version Model Number: 3-Lead, snap stye, AHA, reusable
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	06944413803657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151787

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Holter ECG Cable]

• 06944413803909: 12-Lead, snap stye, IEC, reusable
• 06944413803657: 3-Lead, snap stye, AHA, reusable
• 06944413803640: 3-Lead, snap stye, IEC, reusable
• 06944413803633: 3-Lead, snap stye, AHA, reusable
• 06944413803626: 3-Lead, snap stye, IEC, reusable
• 06944413803619: 12-Lead, snap stye, AHA, reusable