Advantage Plus Endoscope Reprocessing System

GUDID 00677964044755

MEDIVATORS INC.

Endoscope washer/disinfector

• Primary Device ID: 00677964044755
• NIH Device Record Key: c13489b1-e910-4c45-8c80-74f9b30f856e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Plus Endoscope Reprocessing System
• Version Model Number: 1-2-510.003
• 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	00677964044755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082988

FDA Product Code

• FEB: Accessories, Cleaning, For 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: 2016-09-16

Devices Manufactured by MEDIVATORS INC.

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• 50167796415229 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Revital-Ox Bedside Concentrate Kit, Defendo Olympus 5-piece Kit, Transport Pad, Lubricant,
• 50677964152271 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Basin, Intercept Detergent, Dry Sponge, Fuji 700 4-piece Kit, Transport Pad, Absorbant Pad
• 50677964152288 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Basin, Enzymatic Sponge, Transport Pad, Lubricant, Gauze, and BioHazard Label.
• 50677964152295 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Basin, Enzymatic Sponge, BioShield Single-Use Biopsy Valve Kit, Transport Pad, Lubricant,
• 50677964152301 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Basin, Enzymatic Sponge, Defendo Olympus 5-piece Kit, Drawstring Pads, Absorbant Pads, Lubr
• 50677964152318 - Endo Carry-on Procedure Kit: 2025-12-17 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 4-piece Kit, Endo Carry-on Transport Pad, Lubricant,