| Primary Device ID | 00850064686036 |
| NIH Device Record Key | 1ace23b1-0e8b-4551-af40-4cce85ad3493 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiMap Cart |
| Version Model Number | FG0010 |
| Catalog Number | OPTI-CART |
| Company DUNS | 119228234 |
| Company Name | Cortex, Inc. |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850064686036 [Primary] |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-01 |
| Device Publish Date | 2025-07-24 |
| 00850064686005 - OptiMap Amplifer | 2025-08-01 OptiMap Amplifier |
| 00850064686012 - OptiMap™ Workstation | 2025-08-01 OptiMap Workstation |
| 00850064686029 - OptiMap Monitor | 2025-08-01 OptiMap Monitor |
| 00850064686036 - OptiMap Cart | 2025-08-01OptiMap Cart |
| 00850064686036 - OptiMap Cart | 2025-08-01 OptiMap Cart |
| 00850064686043 - OptiMap™ Cable Kit - NA | 2025-08-01 OptiMap Cable Kit - North American |
| 00850064686067 - OptiMap™ Catheter - 50mm | 2025-08-01 The OptiMap™ Catheter is a basket catheter used to detect electrical potentials from the endocardial surfaces of the heart. |
| 00850064686081 - OptiMap™Catheter Extension Cable | 2025-08-01 OptiMap™ Catheter Extension Cable |
| 00850064686098 - OptiMap™ System Interconnect Cable | 2025-08-01 OptiMap™ System Interconnect Cable |