CER-1 Optima

GUDID 00677964052484

MEDIVATORS INC.

Endoscope washer/disinfector

• Primary Device ID: 00677964052484
• NIH Device Record Key: 3a278a55-ce29-430d-8adc-959f991b36bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-1 Optima
• Version Model Number: CER-1 Optima
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964052484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871712

FDA Product Code

• NVE: Washer, Cleaner, Automated, Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

Devices Manufactured by MEDIVATORS INC.

• 50677964150307 - Endo Carry-on Procedure Kit: 2025-05-16 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, BioShield Back Flow Valve for Olympus, Cleanascope Liners, Absorban
• 50677964150314 - Endo Carry-on Procedure Kit: 2025-05-16 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus, 5-piece Kit, Cleanascope Liners, Drawstring Pad, a
• 50677964150321 - Endo Carry-on Procedure Kit: 2025-05-16 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Cleanascope Liners, Transport Pad, Dra
• 50677964150246 - Endo Carry-on Procedure Kit: 2025-05-14 Endo Carry-on Procedure Kit Includes Intercept Bedside Kit, Defendo Olympus 5-piece kit, Drawstring Pad, Absorbent Pad, Lubric
• 50677964150253 - Endo Carry-on Procedure Kit: 2025-05-14 Endo Carry-on Procedure Kit Includes Basin, Sponge, Defendo Olympus EUS 2-pice kit, Absorbant Pad, and Lubricant.
• 50677964150260 - Endo Carry-on Procedure Kit: 2025-05-14 Endo Carry-on Procedure Kit Includes Basin, Sponge, Defendo Olympus EUS 2-pice kit, Absorbant Pad, and Lubricant.
• 50677964150277 - Endo Carry-on Procedure Kit: 2025-05-14 Endo Carry-on Procedure Kit Includes Basin, Sponge, Gauze, Drawstring Pad, Gemini Dual-ended Channel Cleaning Brush, Valve Contr
• 50677964150284 - Endo Carry-on Procedure Kit: 2025-05-14 Endo Carry-on Procedure Kit Includes Basin, Sponge, Defendo Fuji 700 4-pice kit, Transport Pad, Gauze, Double Header Combinatio