Edwards Lifesciences Vascular Torniquet Kit TK2

GUDID 00690103041798

Vascular Torniquet Kit

Edwards Lifesciences LLC

Vascular occluder, single-use Vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal 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

• 00690103217124 - HemoSphere Vita: 2024-03-05 PRESSURE CONTROLLER KIT
• 00690103218848 - HemoSphere Vita: 2024-03-05 VitaWave Module
• 00690103218855 - HemoSphere Vita: 2024-03-05 HemoSphere Vita Monitor
• 00690103218862 - HemoSphere Vita: 2024-03-05 Vita Technology Module
• 50690103218898 - VitaWave: 2024-02-28 VitaWave Finger Cuff Adult
• 00690103217483 - EVOQUE: 2024-02-15 Edwards EVOQUE Stabilizer Plate
• 00690103217490 - EVOQUE: 2024-02-15 Edwards EVOQUE Loading System
• 00690103217506 - EVOQUE: 2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators)