70AND3

GUDID 00690103181555

PRESSURE SLAVE CABLE NOT STERILE

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103181555
• NIH Device Record Key: 245ba070-dab6-46d4-a345-a8a41f7dfa52
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 70AND3
• Catalog Number: 70AND3
• 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

Device Dimensions

• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103181555 [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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• 00690103219760 - SAPIEN M3 Dock Steerable Catheter: 2026-02-09 SAPIEN M3 Dock Steerable Catheter
• 00690103219777 - Edwards Commander M Delivery System: 2026-02-09 Edwards Commander M Delivery System
• 00690103219784 - Edwards 23F Guide Sheath: 2026-02-09 Edwards 23F Guide Sheath
• 00690103219791 - SAPIEN M3 Crimper: 2026-02-09 SAPIEN M3 Crimper
• 50690103000073 - CO-SET INJECTATE ICE BUCKET: 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE
• 00690103002546 - CLAMP FOR DPT HOLDER: 2025-07-23 PRESSURE MONITORING ACCESSORY