DSD Edge Endoscope Reprocessing System

GUDID 00677964046674

MEDIVATORS INC.

Endoscope washer/disinfector

• Primary Device ID: 00677964046674
• NIH Device Record Key: 3cac28f8-0423-4543-91a6-ec04c4cb32f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DSD Edge Endoscope Reprocessing System
• Version Model Number: DSD Edge 120V
• 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	00677964046674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092387

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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• 40677964050891 - Endo Carry-on Procedure Kit: 2024-10-18 Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Olympus 5-piece DCA Kit, Transport Pad, Lubricant, Gauze, Duoswift
• 40677964051157 - Endo Carry-on Procedure Kit: 2024-10-18 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Defendo Olympus 3-piece Valve Kit, Transport Pad, Lubricant, Gauze
• 40677964051294 - Endo Carry-on Procedure Kit: 2024-10-18 Endo Carry-on Procedure Kit includes Basin, Intercept Detergent, Flat Sponge, Cylindrical Sponge, Defendo 4 Piece Valves Kit, Tr
• 40677964051317 - Endo Carry-on Procedure Kit: 2024-10-18 Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Defendo Olympus 4-piece Valve Kit, Transport Pad, Lubricant, Gauze
• 40677964050839 - Endo Carry-on Procedure Kit: 2024-10-11 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Cleanascope Advantage Line
• 40677964050853 - Endo Carry-on Procedure Kit: 2024-10-11 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Drawstring Transport Pad, Absorbent Pad,
• 40677964050952 - Endo Carry-on Procedure Kit: 2024-10-11 Endo Carry-on Procedure Kit Includes Basin, Double Header Channel Valve Brush, Tip Protector and Green Mesh Valve Bag.