Edwards Lifesciences Vent Caps SPC2063

GUDID 00690103036206

Vent Caps

Edwards Lifesciences LLC

Catheter orifice occluder

• Primary Device ID: 00690103036206
• NIH Device Record Key: 25f67d01-ffa9-4b8a-8317-99c7a1ddfa74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards Lifesciences Vent Caps
• Version Model Number: SPC2063
• Catalog Number: SPC2063
• 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: 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	00690103036206 [Primary]
GS1	50690103036201 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861322

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

Devices Manufactured by Edwards Lifesciences LLC

• 57460691952770 - TRUWAVE: 2026-03-30 PRESSURE MONITORING SET
• 57460691955887 - TRUWAVE: 2026-03-30 PRESSURE MONITORING SET
• 00690103000382 - SWAN-GANZ TRUE SIZE: 2026-03-24 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• 50690103218287 - SWAN-GANZ VIP: 2026-03-24 SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER
• 50690103218607 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE THERMODILUTION CATHETER
• 50690103218621 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE CATHETER DOUBLE LUMEN
• 50690103218638 - SWAN-GANZ TRUE SIZE: 2026-03-24 TRUE SIZE MONITORING CATHETER TRIPLE LUMEN
• 00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)