SWAN-GANZ VIP 831F75P

GUDID 50690103218287

SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER

Edwards Lifesciences LLC

Pulmonary artery balloon catheter, electrical

• Primary Device ID: 50690103218287
• NIH Device Record Key: e25f2715-bf4b-42b7-92de-6b4eceeb8963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWAN-GANZ VIP
• Version Model Number: 831F75
• Catalog Number: 831F75P
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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.
• 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.
• 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.
• 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	00690103218282 [Primary]
GS1	50690103218287 [Package]; Contains: 00690103218282; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160084

FDA Product Code

• DYG: CATHETER, FLOW DIRECTED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-24
• Device Publish Date: 2026-03-16

On-Brand Devices [SWAN-GANZ VIP]

• 00690103197396: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH CONTAMINATION SHIELD
• 00690103197303: SWAN-GANZ VIP/OXIMETRY THERMODILUTION CATHETER
• 00690103003031: SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER
• 50690103218287: SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER