Thermodilution 7FR 110cm Modified J-tip

Basic Information

• Brand Name: Thermodilution 7FR 110cm Modified J-tip
• Primary DI: M822474110P0
• Version / Model: 474-110P
• Catalog Number: 474-110P
• Company Name: ALPHA MEDICAL INSTRUMENTS
• Labeler DUNS: 627767577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-08
• Public Version: 6
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 717caa6b-8e83-48c0-9e36-86ac55af8090

Device Description

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: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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

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	M822474110P0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920869	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit