Wedge Pressure 6fr 110cm S-tip

Basic Information

• Brand Name: Wedge Pressure 6fr 110cm S-tip
• Primary DI: M822162110PS2
• Version / Model: 162-110PS
• Catalog Number: 162-110PS
• Company Name: ALPHA MEDICAL INSTRUMENTS
• Labeler DUNS: 627767577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-10
• Public Version: 6
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: af33ce87-3592-42ae-ac38-eceec5797098

Device Description

Wedge Pressure Balloon 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Primary	M822162110PS2	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920873	000

Storage Conditions

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