SWAN-GANZ 015F4

GUDID 00690103000207

NON-BALLOON DUAL LUMEN OXIMETRY CATHETER

Edwards Lifesciences LLC

Oximeter catheter, single-use

• Primary Device ID: 00690103000207
• NIH Device Record Key: c527bf5e-4781-4c8f-8710-ca22e2b55196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWAN-GANZ
• Version Model Number: 015F4
• Catalog Number: 015F4
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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

Device Dimensions

• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103000207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926450

FDA Product Code

• DQE: CATHETER, OXIMETER, FIBEROPTIC

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: 2016-09-03

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