DISPOSABLE BALLOON CATHETER

DISPOSABLE BALLOON CATHETER - B5-2Q

A multi-purpose flexible tube with an inflatable balloon at the distal end designed to be introduced into either the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) or tracheobronchial tree (i.e., capable of both) for the injection/irrigation of fluids (e.g., contrast medium), removal of foreign bodies (e.g., biliary stones, food), and control of bleeding. It typically has more than one lumen and port for the separate introduction of fluids and air, and is introduced via a flexible endoscope. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FGE

Device Name: Stents, Drains And Dilators For The Biliary Ducts

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5010

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170463751

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170463754

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170463754

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A