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.

• 50677964150550 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze, Duosw
• 50677964150567 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Basin, Sponge, Defendo Pentax 4-piece Kit, Transport Pad, Lubricant, Gauze, and Biohazard
• 50677964150574 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Basin, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauze
• 50677964150581 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Basin, Enzymatic Sponge, Fuji 700 4-piece kit, Drawstring Pad, Lubricant, Gauze, Dirty Sc
• 50677964150598 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Sponge, Defendo Olympus 5-piece Kit, Absorbant Pad, Lubricant, Gauz
• 50677964150604 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Transport Pad, Lubricant, Gauze, Duosw
• 50677964150611 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Basin, Sponge, Transport Pad, Gauze, Lubricant, Double Header Combination Channel Valve B
• 50677964150628 - Custom Procedure Kit: 2025-07-02 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo 5-piece Olympus Kit, Drawstring Pad, Gauze, Lubricant, Dou