| Primary Device ID | 00840682106023 |
| NIH Device Record Key | 86e3aaa6-7c0d-49d0-b640-2bc44308b873 |
| Commercial Distribution Discontinuation | 2017-07-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | T2100 |
| Version Model Number | Treadmill |
| Company DUNS | 784985108 |
| Company Name | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 | 00840682106023 [Primary] |
| IOL | TREADMILL, POWERED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-25 |
| 00195278931504 - MLCL Client Software | 2025-05-13 Software Medical Device GE Client Software V9.0 |
| 00195278935632 - Mac-Lab | 2025-05-13 AltiX AI.i Mac-Lab Computer |
| 00195278935656 - CardioLab | 2025-05-13 AltiX AI.i CardioLab Computer |
| 00195278935687 - ComboLab | 2025-05-13 AltiX AI.i ComboLab Computer |
| 00195278940193 - MLCL Upgrade | 2025-05-13 Upgrade Kit MLCL V9.0 |
| 00840682144803 - NA | 2025-05-09 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB 80369-5 DINACLICK FEM, SINGLE |
| 00840682118910 - NA | 2025-05-02 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE |
| 00840682188968 - MLCL Upgrade | 2025-04-21 Upgrade Kit MLCL V7.1 |