Pathfinder® GI 085140

GUDID 00850006222001

NEPTUNE MEDICAL INC.

Endoscopic overtube, single-use

• Primary Device ID: 00850006222001
• NIH Device Record Key: d094c175-60f2-4b0c-bebe-ba5aaaebd44d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder®
• Version Model Number: GI 085140
• Catalog Number: GI 085140
• 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

Customer Support Contacts

• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com
• Phone: 888-202-8401
• Email: info@neptunemedical.com

Device Dimensions

• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter
• Length: 85 Centimeter
• Outer Diameter: 16.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006222001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191415

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: 2020-07-28
• Device Publish Date: 2020-07-20

Devices Manufactured by NEPTUNE MEDICAL INC.

• 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