iT20 ECG cable

GUDID 06944413803695

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944413803695
• NIH Device Record Key: 2598a5ad-3658-427e-b4f4-2d0d3e2cf350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iT20 ECG cable
• Version Model Number: 3-lead, clip,IEC, 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	06944413803695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161056

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: 2017-02-23

On-Brand Devices [iT20 ECG cable]

• 06944413803749: 5-lead, clip,AHA, reusable
• 06944413803732: 5-lead, clip,IEC, reusable
• 06944413803725: 5-lead, snap,AHA, reusable
• 06944413803718: 5-lead, snap,IEC, reusable
• 06944413803701: 3-lead, clip,AHA, reusable
• 06944413803695: 3-lead, clip,IEC, reusable
• 06944413803688: 3-lead, snap,AHA reusable
• 06944413803671: 3-lead, snap,IEC, reusable