Neuroline Cup
- Primary DI
- 05707480146505
- Brand
- Neuroline Cup
- Company
- Ambu A/S
- Model
- 72615-M/23
- Catalog number
- 72615-M/23
- Device description
- Ambu Neuroline Cup, 150 cm leadwire, Colour Kit of 23 pcs .
- Published
- 2021-06-01
- Public version status
- New
- 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 |
|---|
| 05707480146505 | Package | GS1 | 2 | In Commercial Distribution |
| 05707480146512 | Package | GS1 | 20 | In Commercial Distribution |
| 05707480146529 | Primary | GS1 | 0 | |
| 05707480153923 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480146505 | 05707480146505 | 5707480146505 |
| 05707480146512 | 05707480146512 | 5707480146512 |
| 05707480146529 | 05707480146529 | 5707480146529 |
| 05707480153923 | 05707480153923 | 5707480153923 |
GMDN Terms
| Term | Definition |
|---|
| Analytical scalp electrode, single-use | A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. 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 | 150 | Centimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 23
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| Primary DI | Brand | Model | Catalog | Published |
|---|
| 05707480135363 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 520611101 | 520611101 | 2017-10-13 |
| 05707480135585 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523631011 | 523631011 | 2018-07-09 |
| 05707480135615 | SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator | 530639011 | 530639011 | 2017-10-13 |
| 05707480136018 | SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator | 544216047 | 544216047 | 2018-05-28 |
| 05707480145294 | SPUR® II Adult Resuscitator | 524614000 | 524614000 | 2020-06-24 |
| 05707480145317 | SPUR® II Pediatric Resuscitator | 531616000 | 531616000 | 2020-06-24 |
| 05707480145348 | SPUR® II Adult Resuscitator | 520611074 | 520611074 | 2020-06-24 |
| 05707480145393 | SPUR® II Adult Resuscitator | 520211000BE | 520211000BE | 2021-04-13 |
| 05707480145416 | SPUR® II Adult Resuscitator | 520211000E | 520211000E | 2021-04-13 |
| 05707480145430 | SPUR® II Adult Resuscitator | 520211001E | 520211001E | 2021-04-13 |
| 05707480145454 | SPUR® II Adult Resuscitator | 520211010E | 520211010E | 2021-04-13 |
| 05707480145478 | SPUR® II Adult Resuscitator | 520214000E | 520214000E | 2021-04-13 |
| 05707480145492 | SPUR® II Adult Resuscitator | 520611000E | 520611000E | 2021-04-13 |
| 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 |
| 05707480145591 | SPUR® II Adult Resuscitator | 523611031E | 523611031E | 2021-04-13 |
| 05707480027354 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211000 | 523211000 | 2016-12-19 |
| 05707480027361 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211001 | 523211001 | 2016-12-19 |
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