| Primary Device ID | 00810591020031 |
| NIH Device Record Key | 591cbd13-bd5f-4fc9-ae95-037f2c8a853c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIRMap |
| Version Model Number | AR064070 |
| Catalog Number | AR064070 |
| Company DUNS | 080174723 |
| Company Name | ABBOTT |
| 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(650)681-3470 |
| aepcustomerservice@abbott.com | |
| Phone | +1(650)681-3470 |
| aepcustomerservice@abbott.com |
| Circumference | 70 Millimeter |
| Circumference | 70 Millimeter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810591020031 [Primary] |
| MTD | CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-02 |
| 00810591020246 | FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile |
| 00810591020086 | FIRMap Mapping Adapter Connector |
| 00810591020079 | FIRMap Extension Cable - Global, Non-Sterile |
| 00810591020062 | FIRMap Fan Out Cable - US, Non-Sterile |
| 00810591020031 | FIRMap Catheter 70mm, PACKAGED - Abbott (Global) |
| 00810591020024 | FIRMap Catheter 60mm, PACKAGED - Abbott (Global) |
| 00810591020017 | FIRMap Catheter 50mm, PACKAGED - Abbott (Global) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FIRMAP 85427524 4547992 Live/Registered |
Topera, Inc. 2011-09-20 |