SWAN-GANZ TRUE SIZE

Basic Information

• Brand Name: SWAN-GANZ TRUE SIZE
• Primary DI: 00690103218633
• Version / Model: 114F7
• Catalog Number: 114F7P
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-16
• Public Version: 1
• Public Version Date: 2026-03-24
• Public Version Status: New
• Public Device Record Key: cd912134-31ab-4997-a0e2-2ab0a874b50e

Device Description

TRUE SIZE MONITORING CATHETER TRIPLE LUMEN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYG	CATHETER, FLOW DIRECTED	Cardiovascular	870.1240	2
DQE	CATHETER, OXIMETER, FIBEROPTIC	Cardiovascular	870.1230	2
KRA	Catheter, continuous flush	Cardiovascular	870.1210	2
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34925	Pulmonary artery balloon catheter, electrical	A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.	No	Active
35889	Pulmonary artery balloon catheter, non-electrical	A flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50690103218638	GS1	CASE	5	In Commercial Distribution
Primary	00690103218633	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160084	000
K233824	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			EXTERIOR DIAMETER: 7 F (2.3MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.035 IN (0.89 MM), MINIMUM INTRODUCER SIZE: 8 F (2.7 MM)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL, DRY PLACE.