ECG Cable

GUDID 06944413803589

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944413803589
• NIH Device Record Key: 8a6f3760-8a4e-4a4c-8ce8-59e36ba5266b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Cable
• Version Model Number: 18-Lead, Ф4mm Banana, 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	06944413803589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152427

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 [ECG Cable]

• 06944413808911: 12-Lead,Ф4mm,banana,AHA,reusable
• 06944413808904: 12-Lead,Ф4mm,banana,IEC,reusable
• 06944413807051: 3-lead,AHA,Ф4.0mm banana,resuable
• 06944413805156: 5-lead, 6pin, ESU, snap, AHA, reusable
• 06944413805149: 5-lead, 6pin, ESU, snap, IEC, reusable
• 06944413805132: 5-Lead, 6pin, ESU, clip, AHA, reusable
• 06944413805125: 5-lead, 6pin, ESU, clip, IEC, reusable
• 06944413805118: 5-Lead, 12pin, ESU, snap, AHA, reusable
• 06944413805101: 5-Lead, 12pin, ESU, snap, IEC, reusable
• 06944413805095: 5-Lead, 12pin, ESU, clip, AHA, reusable
• 06944413805088: 5-Lead, 12pin, ESU, clip, IEC, reusable
• 06944413805071: 5-lead, 6pin, Defib, snap, AHA, reusable
• 06944413805064: 5-lead, 6pin, Defib, snap, IEC, reusable
• 06944413805057: 5-lead, 6pin, Defib, clip, AHA, reusable
• 06944413805040: 5-lead, 6pin, Defib, clip, IEC, reusable
• 06944413805033: 5-Lead, 12pin, Defib, snap, AHA, reusable
• 06944413805026: 5-Lead, 12pin, Defib, snap, IEC, reusable
• 06944413805019: 5-Lead, 12pin, Defib, clip, AHA, reusable
• 06944413805002: 5-Lead, 12pin, Defib, clip, IEC, reusable
• 06944413804388: 12-lead, clip, IEC, 0.9m, reusable
• 06944413804371: 12-Lead, IEC, snap, reusable
• 06944413804364: 12-lead, clip, IEC, 0.9m, reusable
• 06944413804357: 12-Lead, AHA, snap, reusable
• 06944413804340: 3-Lead, IEC, clip, reusable
• 06944413804333: 3-Lead, AHA, clip, reusable
• 06944413804258: 3-lead, 6pin, ESU, IEC, snap, 3.4m, reusable
• 06944413804241: 3-lead, 12pin, ESU, AHA, snap, 3.4m, reusable
• 06944413804234: 3-lead, 12pin, ESU, IEC, snap, 3.4m, reusable
• 06944413804227: 3-lead, 6pin, Defib, AHA, snap, 3.4m, reusable
• 06944413804210: snap, 3.4m, reusable
• 06944413804203: 3-lead, 12pin, Defib, AHA, snap, 3.4m, reusable
• 06944413804180: 3-lead, 6pin, ESU, AHA, clip, 3.4m, reusable
• 06944413804173: 3-lead, 6pin, ESU, IEC, clip, 3.4m, reusable
• 06944413804166: 3-lead, 12pin, ESU, AHA, clip, 3.4m, reusable
• 06944413804159: 3-lead, 12pin, ESU, IEC, clip, 3.4m, reusable
• 06944413804142: 3-lead, 6pin, Defib, AHA, clip, 3.4m, reusable
• 06944413804135: 3-lead, 6pin, Defib, IEC, clip, 3.4m, reusable
• 06944413804128: 3-lead, 12pin, Defib, AHA, clip, 3.4m, reusable
• 06944413804111: 3-lead, 12pin, Defib, IEC, clip, 3.4m, reusable
• 06944413803947: 5-lead, clip, Defib, IEC, 3.5m, reusable
• 06944413803930: 5-lead, snap, Defib, IEC, 3.5m, reusable
• 06944413803923: 5-lead, clip, Defib, AHA, 3.5m, reusable
• 06944413803916: 5-lead, snap, Defib, AHA, 3.5m, reusable
• 06944413803831: 12-Lead, IEC, Ф4mm Banana, reusable
• 06944413803763: 12-electrode, Banana Ф4mm, AHA
• 06944413803756: 12-electrode, Banana Ф4mm, IEC
• 06944413803602: 12-Lead, Ф4mm Banana, IEC, reusable
• 06944413803596: 12-Lead,Ф4mm Banana,AHA,reusable
• 06944413803589: 18-Lead, Ф4mm Banana, IEC, reusable
• 06944413803572: 18-Lead, Ф4mm Banana, AHA, reusable