Barrx

Basic Information

• Brand Name: Barrx
• Primary DI: 10884521786035
• Version / Model: 1190A-230A
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-03
• Public Version: 1
• Public Version Date: 2024-02-12
• Public Version Status: New
• Public Device Record Key: a4c3f9cd-3b96-48f0-92b8-807a37710307

Device Description

Flex RFA Energy Generator

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
66664	Gastrointestinal radio-frequency ablation system generator	A noninvasive, electrically-powered device designed to generate radio-frequency (RF) electrical current to create heat in the gastrointestinal tract (e.g., oesophagus, stomach, rectum, anus) via a dedicated endoscopic electrode/catheter (not included) for focal ablation; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes controls and display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521786035	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160360	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Electric Pressure,220-240,V;Current,4A 50,Hertz;

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .788 – 1.013 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Handling Environment Humidity
• Temperature Range: 20 – 65 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius