Edwards Lifesciences Vascular Torniquet Kit TK2

GUDID 00690103041798

Vascular Torniquet Kit

Edwards Lifesciences LLC

Vascular occluder, single-use

• Primary Device ID: 00690103041798
• NIH Device Record Key: 5465ea36-692c-482f-94d8-d1e43c214a87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards Lifesciences Vascular Torniquet Kit
• Version Model Number: TK2
• Catalog Number: TK2
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 2
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00690103041798 [Primary]
GS1	50690103041793 [Package]; Package: Shipper [10 Units]; In Commercial Distribution
GS1	70690103041797 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910221

FDA Product Code

• DXC: CLAMP, VASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

Devices Manufactured by Edwards Lifesciences LLC

• 00690103019261 - HEART VALVE SIZER ACCESSORY: 2026-02-18 CARPENTIER-EDWARDS AORTIC OBTURATOR
• 00690103186307 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MGNA MITRAL EASE REPLICA SIZER
• 00690103186314 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186321 - REPLICA SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186338 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186345 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186352 - CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZER: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE REPLICA SIZE
• 00690103186369 - BARREL SIZER FOR MAGNA MITRAL EASE VALVE MODEL 7300TFX, NON-STERILE: 2026-02-18 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE BARREL SIZER