CER-2 Optima

GUDID 00677964052491

MEDIVATORS INC.

Endoscope washer/disinfector

• Primary Device ID: 00677964052491
• NIH Device Record Key: 1fdc3716-86a1-4892-a113-f8e8d8d75dce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-2 Optima
• Version Model Number: CER-2 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964052491 [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.

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• 50677964150802 - Endo Carry-on Procedure Kit: 2025-07-21 Endo Carry-on Procedure Kit contains Basin, Sponge, Defendo Fuji 700 5-piece Kit, Cleanascope Advantage Liners, Transport Pad,
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