CONMED ENDOGATOR PUMP

GUDID 00677964085611

MEDIVATORS INC.

Surgical irrigation/aspiration pump

• Primary Device ID: 00677964085611
• NIH Device Record Key: 5a59493c-b93d-453d-ac6e-5431a014ab98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONMED ENDOGATOR PUMP
• Version Model Number: CETEGP-100
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00677964085611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060962

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-29
• Device Publish Date: 2018-09-28

Devices Manufactured by MEDIVATORS INC.

• 40677964007611 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes DEFENDO Air/Water Suction Biopsy Valve Kit, and Chux Pad
• 40677964007635 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes DEFENDO Air/Water Suction Biopsy, Air Water Jet Valve Kit, and Chux Pad
• 40677964007659 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes Pentax Air Water Suction, and Biopsy Valve Kit Chux Pad
• 40677964007673 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes Pentax 4-piece Valve Kit, and Chux Pad
• 40677964007697 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes DEFENDO Air Water Suction, and Biopsy Valve Kit, and Chux Pad
• 40677964007710 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes DEFENDO Air Water Valve, and Chux Pad
• 40677964007734 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes Pentax Air Water Suction, and Biopsy Valve Kit, and Endo Carry-on Transport Pad
• 40677964007758 - Preclean Kit: 2025-01-29 Preclean Plus Kit includes Pentax 4-piece Valve Kit, and Endo Carry-on Transport Pad