Vascular 896012030

GUDID 00690103218527

CABLE ASSY,10PIN/SIEMENS,MDR

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103218527
• NIH Device Record Key: 7a48d448-37f3-46ee-a607-c5ef502c24c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascular
• Version Model Number: 896012030
• Catalog Number: 896012030
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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	00690103218527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142749

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-16
• Device Publish Date: 2024-08-08

Devices Manufactured by Edwards Lifesciences LLC

• 00690103218527 - Vascular: 2024-08-16CABLE ASSY,10PIN/SIEMENS,MDR
• 00690103218527 - Vascular: 2024-08-16 CABLE ASSY,10PIN/SIEMENS,MDR
• 00690103218534 - PX1800: 2024-08-16 CABLE ASSY,EW TRUWAVE,ROHS,MDR
• 00690103218541 - PX1800: 2024-08-16 CABLE ASSY, 6 PIN/MS3106, MDR
• 00690103218558 - PX1800: 2024-08-16 CBL ASSY,12 PIN/KONTRON,ROHS
• 00690103218565 - PX1800: 2024-08-16 CABLE ASSY, EW SIEMENS, MDR
• 00690103218572 - PX1800: 2024-08-16 CABLE ASSEMBLY,EW, ROHS
• 00690103219265 - FLOTRAC: 2024-08-14 FLOTRAC SENSOR JR
• 00690103219357 - FLOTRAC: 2024-08-14 FLOTRAC SENSOR JR