Pathfinder® CR System

GUDID 00850006222322

The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.

NEPTUNE MEDICAL INC.

Endoscopic suction valve, single-use

• Primary Device ID: 00850006222322
• NIH Device Record Key: b5525133-0907-40f8-8e9c-ab83a236d82a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder® CR System
• Version Model Number: GI 014CR-1
• Company DUNS: 075588994
• Company Name: NEPTUNE MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006222322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240853

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-17
• Device Publish Date: 2024-07-09

Devices Manufactured by NEPTUNE MEDICAL INC.

• 00850006222322 - Pathfinder® CR System: 2024-07-17The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices.
• 00850006222322 - Pathfinder® CR System: 2024-07-17 The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It
• 00850006222025 - Pathfinder® Endoscope Overtube with Balloon: 2023-11-28
• 00850006222124 - Pathfinder® Endoscope Overtube with Balloon: 2023-11-28
• 00850006222049 - Pathfinder® Endoscope Overtube: 2021-09-08
• 00850006222056 - Pathfinder® Endoscope Overtube: 2021-09-08
• 00850006222063 - Pathfinder® Endoscope Overtube: 2021-09-08
• 00850006222070 - Pathfinder® Endoscope Overtube: 2021-06-15
• 00850006222087 - Pathfinder® Endoscope Overtube: 2021-06-15