AccessGUDID - DEVICE: Barrx (10884521786035)

GUDID

Device Identifier (DI) Information

Brand Name: Barrx
Version or Model: 1190A-230A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521786035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Flex RFA Energy Generator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160360	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Handling Environment Temperature: between 20 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 79 and 101 KiloPascal

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: a4c3f9cd-3b96-48f0-92b8-807a37710307
Public Version Date: June 24, 2025
Public Version Number: 5
DI Record Publish Date: February 03, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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