DRIVEMEDICAL
- Primary DI
- 00822383935355
- Brand
- DRIVEMEDICAL
- Company
- Drive Devilbiss Healthcare
- Model
- AGF-6X2
- Device description
- ElectrotherapyMuscle Stim Product Description: Digital EMS Deluxe,1/box
- Published
- 2017-04-05
- 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 |
|---|
| GZJ | STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50822383935350 | Package | GS1 | 30 | In Commercial Distribution |
| 00822383935355 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 50822383935350 | 50822383935350 | | |
| 00822383935355 | 00822383935355 | 822383935355 | 0822383935355 |
GMDN Terms
| Term | Definition |
|---|
| Transcutaneous electrical stimulation electrode | A non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. |
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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