Barrx

GUDID 10884521177796

Flex RFA Energy Generator

Covidien LP

Radio-frequency ablation system

• Primary Device ID: 10884521177796
• NIH Device Record Key: 7cf527d3-fd09-4af6-8831-c75669aeaef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barrx
• Version Model Number: 1190A-115A
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521177796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092487

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-08
• Device Publish Date: 2016-09-24

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• 10884521189362: 90 RFA Focal Catheter,80 Applications
• 10884521189348: 360 RFA Balloon Catheter
• 10884521189331: 360 RFA Balloon Catheter
• 10884521189324: 360 RFA Balloon Catheter
• 10884521189317: 360 RFA Balloon Catheter
• 10884521189300: 360 RFA Balloon Catheter
• 10884521176621: Channel RFA Endoscopic Catheter,Esophageal TTS, 120 Applications
• 20884521176611: Channel RFA Endoscopic Catheter
• 20884521189420: RFA Cleaning Cap
• 20884521189413: RFA Cleaning Cap
• 10884521189409: 360 Classic Sizing Balloon
• 10884521516311: RFA Endoscopic Guidewire
• 10884521189454: RFA Endoscopic Guidewire
• 10884521211599: Barrx RFA Self Sizing Balloon Catheter
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• 10884521189355: 360 Soft Sizing Balloon
• 10884521181304: Barrx Flex RFA Footswitch
• 10884521181298: Barrx Flex RFA Output Cable
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• 10884521786035: Flex RFA Energy Generator
• 10884521181281: Flex RFA Energy Generator
• 10884521581845: 60 RFA Focal Catheter 80 Applications
• 10884521581838: Ultra Long RFA Focal Catheter 80 Applications
• 10884521581821: 90 RFA Focal Catheter Chang Cap, 80 Applications
• 10884521581753: Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications
• 10884521581876: 360 Express RFA Balloon Catheter