DRIVEMEDICAL
- Primary DI
- 50822383104329
- Brand
- DRIVEMEDICAL
- Company
- Drive Devilbiss Healthcare
- Model
- AGF-104
- Device description
- ElectrotherapyAccessories Product Description: PreGelled 2 Butterfly Elec.1pk/ea
- 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 |
|---|
| 10822383104321 | Package | GS1 | 160 | In Commercial Distribution |
| 50822383104329 | Package | GS1 | 20 | In Commercial Distribution |
| 00822383104324 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10822383104321 | 10822383104321 | | |
| 50822383104329 | 50822383104329 | | |
| 00822383104324 | 00822383104324 | 822383104324 | 0822383104324 |
GMDN Terms
| Term | Definition |
|---|
| Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. |
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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