| Primary Device ID | 00810188050021 |
| NIH Device Record Key | 359b7f8a-f658-4fe7-ac11-eee1d1b1b85b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioness Integrated System (BITS) Bedside Configuration |
| Version Model Number | BIT-2124 |
| Company DUNS | 119378513 |
| Company Name | Bioness Medical, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
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| 00810188050021 - Bioness Integrated System (BITS) Bedside Configuration | 2025-07-28Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software |
| 00810188050021 - Bioness Integrated System (BITS) Bedside Configuration | 2025-07-28 Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software |
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| 00810188050052 - L360 Thigh System | 2025-07-28 L360 Thigh System Kit, Right |
| 00810188050083 - L300 Go System | 2025-07-28 L300 Go System, Left Lower |
| 00810188050120 - L300 Go System | 2025-07-28 L300 Go System, Left Thigh Plus |
| 00810188050175 - L100 Go System | 2025-07-28 L100 Go System, Left |
| 00810188050274 - L300 Go System | 2025-07-28 Quick Fit Electrode, Right |