FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Neuroline CupNeurology Surface Electrode
DI: 05707480133697
·
Model: 72615-M-CM-10
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- Neuroline CupNeurology Surface Electrode
- Primary DI
- 05707480133697
- Version / Model
- 72615-M-CM-10
- Catalog Number
- 72615-M-CM-10
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 3756426b-42ee-4b45-a35b-b9756ec96be1
- Distribution End Date
- 2021-10-05
Device Description
Cup Electrodes - ConMed Colour Kit of 10 pcs (150 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | ELECTRODE, CUTANEOUS | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11440 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480133673 | GS1 | 8 | Not in Commercial Distribution | 2021-10-05 | |
| Package | 05707480133680 | GS1 | 12 | Not in Commercial Distribution | 2021-10-05 | |
| Primary | 05707480133697 | GS1 | ||||
| Unit of Use | 05707480133703 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Inch | |
| Length | 150 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius