| Primary Device ID | 03665023000498 |
| NIH Device Record Key | 199a4ecf-3497-4cea-8c89-7713ee85e516 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOF-S2_B |
| Version Model Number | TOF-S2_B |
| Catalog Number | TOF-S2_B |
| Company DUNS | 260233256 |
| Company Name | IDMED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 03665023000498 [Primary] |
| KOI | Stimulator, Nerve, Peripheral, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2020-03-20 |
| 03665023000535 - WiTOF | 2025-12-29 Main unit WiTOF (branded IDMED) |
| 03665023000542 - WiTOF | 2025-12-29 WiTOF main unit (branded Draeger) |
| 03665023000559 - WiTOF | 2025-12-29 Hand sensor and electrodes connector |
| 03665023000566 - WiTOF | 2025-12-29 WiTOF complete kit (WiTOF-MU, power supply, clamp, hand sensor (WiTOF-S), user manual) |
| 03665023000573 - WiTOF | 2025-12-29 Foot sensor and electrodes connector |
| 03665023000610 - WiTOF | 2025-12-29 WiTOF Demonstration kit (WiTOF-MU, power supply, clamp, hand and foot sensors (WiTOFS and WiTOF-FS), user manual, patient simula |
| 03665023000948 - CuffGuard | 2025-12-29 CuffGuard main unit (branded Idmed) |
| 03665023000955 - CuffGuard | 2025-12-29 CuffGuard main unit (branded Draeger) |