CleanGuard 200310

GUDID 30653405986489

CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve, Biopsy Valve and Auxiliary Water Connector

Conmed Corporation

Endoscope channel support kit

• Primary Device ID: 30653405986489
• NIH Device Record Key: 8cda8cf9-22ff-45ac-bef2-c71f019ed353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CleanGuard
• Version Model Number: 200310
• Catalog Number: 200310
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 200
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405986488 [Unit of Use]
GS1	10653405986485 [Primary]
GS1	30653405986489 [Package]; Contains: 10653405986485; Package: CARTON [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182998

FDA Product Code

• OCX: endoscopic irrigation/suction system

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [CleanGuard]

• 30653405986472: CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve and Biopsy V
• 30653405986489: CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve, Biopsy Valv