Barrx

GUDID 10884521581845

60 RFA Focal Catheter 80 Applications

Covidien LP

Gastrointestinal radio-frequency ablation system catheter

• Primary Device ID: 10884521581845
• NIH Device Record Key: c84f953e-36c7-4cc1-9121-6f2a7498e1bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barrx
• Version Model Number: 90-9300
• 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: 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(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 Dimensions

• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter
• Length: 15 Millimeter
• Width: 10 Millimeter

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 79 KiloPascal and 0 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521581845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112454

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

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: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [Barrx]

• 10884521189386: 60 RFA Focal Catheter,80 Applications
• 10884521189379: Ultra Long RFA Focal Catheter,80 Applications
• 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
• 10884521177796: Flex RFA Energy Generator
• 10884521660694: Flex RFA Energy Generator
• 10884521546295: Anorectal RFA Wand 15mm x 10mm
• 10884521546264: Cytosponge Cell Collection Kit
• 10884521546257: Cytosponge Cell Collection Kit
• 20884521189390: 90M RFA Focal Catheter,40 Applications
• 10884521189355: 360 Soft Sizing Balloon
• 10884521181304: Barrx Flex RFA Footswitch
• 10884521181298: Barrx Flex RFA Output Cable
• 10884521823624: BARRX GEN 115V REFURB 1190A-115A-01-R
• 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
• 20884521581866: RFA Cleaning Cap Medium
• 20884521581859: RFA Cleaning Cap Small