Barrx

Basic Information

• Brand Name: Barrx
• Primary DI: 10884521581821
• Version / Model: 90-9100
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-04
• Public Version: 3
• Public Version Date: 2025-06-24
• Public Version Status: Update
• Public Device Record Key: 42fd966f-8b51-4631-b911-96b52ba823ff

Device Description

90 RFA Focal Catheter Chang Cap, 80 Applications

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66665	Gastrointestinal radio-frequency ablation system catheter	A semi-flexible tubular device with a bipolar electrode(s) at its distal end intended to be endoscopically introduced into the gastrointestinal (GI) tract (e.g., oesophagus, stomach, rectum, anus) to deliver radio-frequency (RF) current from a connected RF generator (not included) for focal ablation of a GI lesion (e.g., neoplasm); it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a closed fluid circuit for cooling of the tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521581821	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093008	000

Device Sizes

Type	Value	Unit	Text
Length	20	Millimeter
Width	13	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 65 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 79 – KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry