Primary Device ID | 10884521581845 |
NIH Device Record Key | c84f953e-36c7-4cc1-9121-6f2a7498e1bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Barrx |
Version Model Number | 90-9300 |
Company DUNS | 058614483 |
Company Name | Covidien LP |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com | |
Phone | +1(508)261-8000 |
covidien.udi@covidien.com |
Length | 15 Millimeter |
Width | 10 Millimeter |
Length | 15 Millimeter |
Width | 10 Millimeter |
Length | 15 Millimeter |
Width | 10 Millimeter |
Length | 15 Millimeter |
Width | 10 Millimeter |
Length | 15 Millimeter |
Width | 10 Millimeter |
Length | 15 Millimeter |
Width | 10 Millimeter |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 79 KiloPascal and 0 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10884521581845 [Primary] |
GEI | Electrosurgical, cutting & coagulation & accessories |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-12 |
Device Publish Date | 2024-11-04 |
10884521189386 | 60 RFA Focal Catheter,80 Applications |
10884521189379 | Ultra Long RFA Focal Catheter,80 Applications |
10884521189362 | 90 RFA Focal Catheter,80 Applications |
10884521189348 | 360 RFA Balloon Catheter |
10884521189331 | 360 RFA Balloon Catheter |
10884521189324 | 360 RFA Balloon Catheter |
10884521189317 | 360 RFA Balloon Catheter |
10884521189300 | 360 RFA Balloon Catheter |
10884521176621 | Channel RFA Endoscopic Catheter,Esophageal TTS, 120 Applications |
20884521176611 | Channel RFA Endoscopic Catheter |
20884521189420 | RFA Cleaning Cap |
20884521189413 | RFA Cleaning Cap |
10884521189409 | 360 Classic Sizing Balloon |
10884521516311 | RFA Endoscopic Guidewire |
10884521189454 | RFA Endoscopic Guidewire |
10884521211599 | Barrx RFA Self Sizing Balloon Catheter |
10884521177796 | Flex RFA Energy Generator |
10884521660694 | Flex RFA Energy Generator |
10884521546295 | Anorectal RFA Wand 15mm x 10mm |
10884521546264 | Cytosponge Cell Collection Kit |
10884521546257 | Cytosponge Cell Collection Kit |
20884521189390 | 90M RFA Focal Catheter,40 Applications |
10884521189355 | 360 Soft Sizing Balloon |
10884521181304 | Barrx Flex RFA Footswitch |
10884521181298 | Barrx Flex RFA Output Cable |
10884521823624 | BARRX GEN 115V REFURB 1190A-115A-01-R |
10884521786035 | Flex RFA Energy Generator |
10884521181281 | Flex RFA Energy Generator |
10884521581845 | 60 RFA Focal Catheter 80 Applications |
10884521581838 | Ultra Long RFA Focal Catheter 80 Applications |
10884521581821 | 90 RFA Focal Catheter Chang Cap, 80 Applications |
10884521581753 | Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BARRX 85560393 4221763 Live/Registered |
COVIDIEN LP 2012-03-05 |