SWAN-GANZ HI-SHORE TRUE SIZE

Basic Information

• Brand Name: SWAN-GANZ HI-SHORE TRUE SIZE
• Primary DI: 00690103017830
• Version / Model: T123F6
• Catalog Number: T123F6
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 6
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: e1d77b24-5b6f-46a0-9454-6c2310e90426

Device Description

HI TORQUE SG FLOW DIRECTED MONIT CATH W/ BONDED BALLOON

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
DQE	CATHETER, OXIMETER, FIBEROPTIC	Cardiovascular	870.1230	2
DYG	CATHETER, FLOW DIRECTED	Cardiovascular	870.1240	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103017830	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160084	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			EXTERIOR DIAMETER: 6F (2.0MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.030 IN (0.76 MM), MINIMUM INTRODUCER SIZE: 6F (2.0MM)

Storage Conditions

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