Defendo Single Use Valve Kit

GUDID 10677964090919

MEDIVATORS INC.

Endoscope channel support kit

• Primary Device ID: 10677964090919
• NIH Device Record Key: 8ed46587-cfb4-4720-b657-03f2271828b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defendo Single Use Valve Kit
• Version Model Number: 100311
• 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	00677964090912 [Primary]
GS1	10677964090919 [Package]; Contains: 00677964090912; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090851

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-16
• Device Publish Date: 2022-02-08

On-Brand Devices [Defendo Single Use Valve Kit]

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