FDA UDI
In Commercial Distribution
🇺🇸 United States
TENS Pros
DI: 00092237626245
·
Model: TP-GE2035TC
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- TENS Pros
- Primary DI
- 00092237626245
- Version / Model
- TP-GE2035TC
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-27
- Public Version
- 2
- Public Version Date
- 2024-10-07
- Public Version Status
- Update
- Public Device Record Key
- dc7daf20-9450-41bb-9c03-4b73ef685fee
Device Description
TENS Pro Gold Electrodes, 2" x 3.5" Rectangle, Tan cloth, foil bag
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30092237626246 | GS1 | CARTON | 40 | In Commercial Distribution | |
| Primary | 00092237626245 | GS1 | ||||
| Package | 80092237626241 | GS1 | CARTON | 8 | In Commercial Distribution | |
| Package | 20092237626249 | GS1 | CARTON | 50 | In Commercial Distribution | |
| Package | 50092237626240 | GS1 | CARTON | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]