Barrx

GUDID 10884521581845

60 RFA Focal Catheter 80 Applications

Covidien LP

Gastrointestinal radio-frequency ablation system catheter
Primary Device ID10884521581845
NIH Device Record Keyc84f953e-36c7-4cc1-9121-6f2a7498e1bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrx
Version Model Number90-9300
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Length15 Millimeter
Width10 Millimeter
Length15 Millimeter
Width10 Millimeter
Length15 Millimeter
Width10 Millimeter
Length15 Millimeter
Width10 Millimeter
Length15 Millimeter
Width10 Millimeter
Length15 Millimeter
Width10 Millimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 79 KiloPascal and 0 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521581845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-12
Device Publish Date2024-11-04

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10884521189348360 RFA Balloon Catheter
10884521189331360 RFA Balloon Catheter
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10884521189300360 RFA Balloon Catheter
10884521176621Channel RFA Endoscopic Catheter,Esophageal TTS, 120 Applications
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20884521189420RFA Cleaning Cap
20884521189413RFA Cleaning Cap
10884521189409360 Classic Sizing Balloon
10884521516311RFA Endoscopic Guidewire
10884521189454RFA Endoscopic Guidewire
10884521211599Barrx RFA Self Sizing Balloon Catheter
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10884521546264Cytosponge Cell Collection Kit
10884521546257Cytosponge Cell Collection Kit
2088452118939090M RFA Focal Catheter,40 Applications
10884521189355360 Soft Sizing Balloon
10884521181304Barrx Flex RFA Footswitch
10884521181298Barrx Flex RFA Output Cable
10884521823624BARRX GEN 115V REFURB 1190A-115A-01-R
10884521786035Flex RFA Energy Generator
10884521181281Flex RFA Energy Generator
1088452158184560 RFA Focal Catheter 80 Applications
10884521581838Ultra Long RFA Focal Catheter 80 Applications
1088452158182190 RFA Focal Catheter Chang Cap, 80 Applications
10884521581753Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications

Trademark Results [Barrx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BARRX
BARRX
85560393 4221763 Live/Registered
COVIDIEN LP
2012-03-05

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