64EKNK1

GUDID 00690103181500

ECG SLAVE CABLE

Edwards Lifesciences LLC

Electrocardiographic lead set, reusable

• Primary Device ID: 00690103181500
• NIH Device Record Key: 4096a9ea-55a3-4f70-97bc-c3a4b3de1896
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 64EKNK1
• Catalog Number: 64EKNK1
• 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: false
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet
• Length: 8 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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	00690103181500 [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

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
• 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS: 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
• 00690103019339 - HEART VALVE ACCESSOR: 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
• 00690103166989 - HEART VALVE ACCESSOR: 2024-10-28 MITRAL SIZER HANDLE
• 00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46: 2024-10-28 RING HANDLE - EXTENDED 4"
• 00690103186437 - FLEXIBLE HANDLE: 2024-10-28 FLEXIBLE HANDLE
• 00690103210132 - MITRIS Handle 1140M: 2024-10-28 11400M valve handle
• 00690103217773 - Edwards EVOQUE Loading System: 2024-10-11 Edwards EVOQUE Loading System