DRIVEMEDICAL
- Primary DI
- 10822383104352
- Brand
- DRIVEMEDICAL
- Company
- Drive Devilbiss Healthcare
- Model
- AGF-107
- Device description
- ElectrotherapyAccessories Product Description: Elec.4PreGelled,7.5cmRd,4/pkg
- Published
- 2016-07-01
- Public version status
- Update
- Distribution status
- Not 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 |
|---|
| 10822383104352 | Package | GS1 | 240 | Not in Commercial Distribution |
| 50822383104350 | Package | GS1 | 30 | Not in Commercial Distribution |
| 00822383104355 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10822383104352 | 10822383104352 | | |
| 50822383104350 | 50822383104350 | | |
| 00822383104355 | 00822383104355 | 822383104355 | 0822383104355 |
GMDN Terms
| Term | Definition |
|---|
| Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. |
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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| 00822383000213 | Drive | 35MCBE-A-SC05 | 35MCBE-A-SC05 | 2025-09-02 |
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