DRIVEMEDICAL
- Primary DI
- 00822383104508
- Brand
- DRIVEMEDICAL
- Company
- Drive Devilbiss Healthcare
- Model
- AGF-3X
- Device description
- ElectrotherapyTens Product Description: TENS Unit, Dlx Horizntal, 1/bx
- Published
- 2016-07-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| GXY | ELECTRODE, CUTANEOUS |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GXY | Electrode, Cutaneous | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50822383104503 | Package | GS1 | 20 | In Commercial Distribution |
| 00822383104508 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 50822383104503 | 50822383104503 | | |
| 00822383104508 | 00822383104508 | 822383104508 | 0822383104508 |
GMDN Terms
| Term | Definition |
|---|
| Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. |
Regulatory Flags
- DUNS number
- 867673159
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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