SWAN-GANZ SGPT755P

GUDID 50690103219383

Swan-Ganz Thermodilution Pediatric

Edwards Lifesciences LLC

Pulmonary artery balloon catheter, electrical

• Primary Device ID: 50690103219383
• NIH Device Record Key: 848571e4-31fa-435f-a228-9e962f1dd421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWAN-GANZ
• Version Model Number: SGPT755P
• Catalog Number: SGPT755P
• 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: 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: 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
• 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
• 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.
• 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	00690103219388 [Primary]
GS1	50690103219383 [Package]; Contains: 00690103219388; Package: SHIPPING [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231248

FDA Product Code

• DQE: Catheter, Oximeter, Fiber-Optic

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: 2024-08-13
• Device Publish Date: 2024-08-05

On-Brand Devices [SWAN-GANZ]

• 00690103197389: SWAN-GANZ THERMODILUTION CATHETER WITH CONTAMINATION SHIELD
• 00690103197358: SWAN-GANZ OXIMETRY THERMODILUTION CATHETER
• 00690103197327: SWAN-GANZ CCO V THERMODILUTION CATHETER
• 00690103161236: CATHETER / INTRODUCER SYSTEM NON-LATEX
• 00690103150438: SWAN-GANZ BIPOLAR PACING CATHETER
• 00690103150421: SWAN-GANZ BIPOLAR PACING CATHETER
• 00690103147315: SWAN-GANZ PACING TD CATHETER
• 00690103003109: SG PEDIATRIC MONITOR CATH 4F 60CM, FLOW DIRECTED, DBL LUM.
• 00690103002799: CABLE CCO CATHETER INTERFACE
• 00690103000474: SWAN-GANZ THERMODILUTION CATHETER
• 00690103000405: SWAN-GANZ THERMODILUTION CATHETER
• 00690103000269: SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER
• 00690103000221: NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
• 00690103000207: NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
• 50690103198558: SWAN-GANZ THERMODILUTION CATHETER
• 00690103217704: Patient CCO cable - HemoSphere Alta advanced monitoring platform
• 50690103219383: Swan-Ganz Thermodilution Pediatric