| Primary Device ID | 00812537037127 |
| NIH Device Record Key | bf63c8e3-1f33-426f-a276-84cccc5381e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TD2 Patient Kit |
| Version Model Number | 74011 |
| Company DUNS | 067140761 |
| Company Name | NALU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | 1-800-618-3402 |
| Info@nalumed.com | |
| Phone | 1-800-618-3402 |
| Info@nalumed.com | |
| Phone | 1-800-618-3402 |
| Info@nalumed.com | |
| Phone | 1-800-618-3402 |
| Info@nalumed.com | |
| Phone | 1-800-618-3402 |
| Info@nalumed.com | |
| Phone | 1-800-618-3402 |
| Info@nalumed.com |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812537037127 [Primary] |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-02 |
| Device Publish Date | 2026-02-20 |
| 00812537037127 - TD2 Patient Kit | 2026-03-02TD2 Patient Kit |
| 00812537037127 - TD2 Patient Kit | 2026-03-02 TD2 Patient Kit |
| 00812537030234 - Therapy Disc | 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu |
| 00812537032399 - Therapy Disc | 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu |
| 00812537035802 - Therapy Disc, Reduced Warranty | 2026-01-27 The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pu |
| 00812537037134 - TD2 Therapy Disc | 2026-01-27 TD2 Therapy Disc a-la-carte |
| 00812537037660 - Nalu Medical, Inc. | 2025-12-16 Trial Lead Kit (8 contact, 40 cm) |
| 00812537037189 - Nalu Medical, Inc. | 2024-05-09 Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm) |
| 00812537037196 - Nalu Medical, Inc. | 2024-05-09 Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm) |