Endogator Hybrid Irrigation Tubing 4000838

GUDID 40677964011205

ENDOGATOR Hybrid Irrigation Tubing with CO2 Connection for certain Olympus GI Endoscopes and Boston Scientific Endostat II Pump Irrigation units.

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 40677964011205
• NIH Device Record Key: c8fec86e-7215-4e19-b571-52b7d13c0421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endogator Hybrid Irrigation Tubing
• Version Model Number: 4000838
• Catalog Number: 4000838
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	40677964011205 [Unit of Use]
GS1	40677964011212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102855

FDA Product Code

• OCX: endoscopic irrigation/suction system

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: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by MEDIVATORS INC.

• 50677964151335 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Basin, VIA Sponge, Defendo Fuji 700 5-Piece Kit, Absorbant Pad, Lubricant, Gauze, and DuoSw
• 50677964151342 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Revital Ox Bedside Concentrate, Defendo Olympus 5-Piece Kit, Drawstring Pad, Absorbant Pads
• 50677964151359 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Olympus 4-Piece Kit, Cleanascope Advantage Liners, Abs
• 50677964151366 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-Piece Kit, Drawstring Pad, Extra Absorbant Pad, Lu
• 50677964151373 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Basin, Defendo Olympus 5-Piece Kit, Transport Pad, Lubricant, Gauze, and Biohazard Sticker.
• 50677964151380 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-Piece Kit, Take-Out Transport Pad, Lubricant, Gauz
• 50677964151397 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Intercept Detergent Packet, Flat Sponge, Cylindrical Sponge, STERIS Fuji 700 4-Piece Kit, D
• 50677964151403 - Endo Carry-on Procedure Kit: 2025-08-25 Endo Carry-on Procedure Kit contains Intercept Bedside Complete Kit, Defendo Olympus 5-Piece Kit, Drawstring Pad, Lubricant, Gau