64EKSM

GUDID 00690103191165

CABLE ECG MONITOR SIEMENS 700/ 9000 C/ DIN 14 PIN

Edwards Lifesciences LLC

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 00690103191165
• NIH Device Record Key: bf96cab3-249d-404f-817a-90d6d9d4b2cc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 64EKSM
• Catalog Number: 64EKSM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 9 Feet
• Length: 9 Feet

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103191165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043103

FDA Product Code

• DXG: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

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: 2016-09-03

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• 00690103218862 - HemoSphere Vita: 2024-03-05 Vita Technology Module
• 50690103218898 - VitaWave: 2024-02-28 VitaWave Finger Cuff Adult
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• 00690103217490 - EVOQUE: 2024-02-15 Edwards EVOQUE Loading System
• 00690103217506 - EVOQUE: 2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)