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.

• 40677964049857 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Defendo Olympus 3-piece Valve Kit, Drawstring Transport Pad, Lubri
• 40677964049871 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Drawstring Transport Pad, Lubricant, Gauze, Double Ended Channel C
• 40677964049895 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Defendo Olympus 3-piece Valve Kit, Absorbent Pad, Lubricant, Gauze, Double Header Channel V
• 40677964049918 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit includes Basin,Enzymatic Sponge, Transport Pad, Lubricant, Gauze and Biohazard Sticker.
• 40677964050013 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Defendo Olympus 4-piece Valve Kit, Lubricant and Duoswift Squeegee Brush.
• 40677964050037 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, Absorbent Pad, Lubricant and Gauze.
• 40677964050051 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, Defendo Olympus 2-piece Valve Kit, Bioshiel
• 40677964050075 - Endo Carry-on Procedure Kit: 2024-08-15 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Flat Sponge, 5-piece Olympus DCA Kit, Cleanascope Advantage Lin