CONMED CLEARGUARD 00522B

GUDID 10653405063247

CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES

Conmed Corporation

Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 10653405063247
• NIH Device Record Key: b1c2b075-5aae-4317-8b7e-eaa7fbe8ba98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONMED CLEARGUARD
• Version Model Number: 00522B
• Catalog Number: 00522B
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 400
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405063240 [Unit of Use]
GS1	10653405063247 [Package]; Contains: 20653405063244; Package: CASE [400 Units]; In Commercial Distribution
GS1	20653405063244 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

On-Brand Devices [CONMED CLEARGUARD]

• 10653405063254: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
• 10653405063247: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES
• 20653405063268: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
• 20653405063237: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES