AccessGUDID - DEVICE: Barrx (10884521581753)

GUDID

Device Identifier (DI) Information

Brand Name: Barrx
Version or Model: TTS-1100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521581753
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications

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:	Yes
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 [?]
K130623	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 15.7 Millimeter
Width: 7.5 Millimeter

Device Record Status

Public Device Record Key: 51d4b6b2-0311-4cda-a72e-08b8927f634d
Public Version Date: June 24, 2025
Public Version Number: 3
DI Record Publish Date: November 04, 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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