DEFENDO SINGLE USE VALVE KIT

GUDID 00677964092992

MEDIVATORS INC.

Device lumen cleaning attachment, single-use

• Primary Device ID: 00677964092992
• NIH Device Record Key: 3dab36fc-89bb-43be-b017-98744ebce33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFENDO SINGLE USE VALVE KIT
• Version Model Number: 100322
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964092992 [Primary]
GS1	40677964009998 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090851

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid
• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-06-04

On-Brand Devices [DEFENDO SINGLE USE VALVE KIT]

• 40677964001367: 4000096
• 00677964103926: 100323
• 00677964092992: 100322
• 10677964094696: 100313
• 10677964094689: 100312
• 10677964090919: 100311
• 40677964024397: DEFENDO Air Water, Suction and Cleaning Adapter with ENDOGATOR connector for Olympus GI Endoscop
• 40677964024373: DEFENDO Air Water, Suction and Cleaning Adapter for Olympus GI Endoscopes
• 10677964094702: Defendo 3-piece kit, Air Water, Suction, and Biopsy Valves