Barrx
GUDID 10884521581821
90 RFA Focal Catheter Chang Cap, 80 Applications
Covidien LP
Gastrointestinal radio-frequency ablation system catheter| Primary Device ID | 10884521581821 |
| NIH Device Record Key | 42fd966f-8b51-4631-b911-96b52ba823ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrx |
| Version Model Number | 90-9100 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
| Length | 20 Millimeter |
| Width | 13 Millimeter |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521581821 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093008
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-12 |
| Device Publish Date | 2024-11-04 |
On-Brand Devices [Barrx]
| 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 |
| 10884521581876 | 360 Express RFA Balloon Catheter |
| 20884521581866 | RFA Cleaning Cap Medium |
| 20884521581859 | RFA Cleaning Cap Small |
Trademark Results [Barrx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BARRX 85560393 4221763 Live/Registered |
COVIDIEN LP 2012-03-05 |
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