Swan-Ganz True Size

Basic Information

• Brand Name: Swan-Ganz True Size
• Primary DI: 00690103198638
• Version / Model: 132NX5
• Catalog Number: 132NX5
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-17
• Public Version: 3
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 571551b1-0aa5-4547-89f5-1ec66f9cc893

Device Description

SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2
DYG	Catheter, Flow Directed	Cardiovascular	870.1240	2
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	870.1230	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103198638	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193466	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Exterior Diameter: 5F, Usable Length 75cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.