Neuroline 710Neurology Surface Electrodes
- Primary DI
- 05707480022502
- Brand
- Neuroline 710Neurology Surface Electrodes
- Company
- Ambu A/S
- Model
- 71010-K/12
- Catalog number
- 71010-K/12
- Device description
- Solid Gel Electrodes K Connector Lead Wire Length: 100 cm (40")
- Published
- 2016-09-21
- 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
- true
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 |
|---|
| 05707480000579 | Package | GS1 | 8 | In Commercial Distribution |
| 05707480022502 | Package | GS1 | 10 | In Commercial Distribution |
| 05707480022632 | Primary | GS1 | 0 | |
| 05707480023554 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480000579 | 05707480000579 | 5707480000579 |
| 05707480022502 | 05707480022502 | 5707480022502 |
| 05707480022632 | 05707480022632 | 5707480022632 |
| 05707480023554 | 05707480023554 | 5707480023554 |
GMDN Terms
| Term | Definition |
|---|
| Analytical non-scalp cutaneous electrode | A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 40 | Inch |
| Length | 100 | Centimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 12
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 05707480145515 | SPUR® II Adult Resuscitator | 521611000E | 521611000E | 2021-04-13 |
| 05707480145539 | SPUR® II Adult Resuscitator | 523211000E | 523211000E | 2021-04-13 |
| 05707480145553 | SPUR® II Adult Resuscitator | 523211001E | 523211001E | 2021-04-13 |
| 05707480145577 | SPUR® II Adult Resuscitator | 523611030E | 523611030E | 2021-04-13 |
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| 05707480027361 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211001 | 523211001 | 2016-12-19 |
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