FDA UDI
In Commercial Distribution
🇺🇸 United States
TD2 Patient Kit
DI: 00812537037127
·
Model: 74011
·
NALU MEDICAL, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TD2 Patient Kit
- Primary DI
- 00812537037127
- Version / Model
- 74011
- Company Name
- NALU MEDICAL, INC.
- Labeler DUNS
- 067140761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-20
- Public Version
- 2
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- bf63c8e3-1f33-426f-a276-84cccc5381e9
Device Description
A non-sterile kit containing two external wearable (2) therapy discs, one (1) Base Station Charger, wall adapter, USB Cable and a carrying case.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | 882.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
| 61588 | Implantable spinal cord electrical stimulation system programmer | A battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812537037127 | GS1 |
Customer Contacts
- Phone
- 1-800-618-3402
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 107 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius