FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuroline 715
DI: 05707480158706
·
Model: 71512-M/C/12
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
12
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Basic Information
- Brand Name
- Neuroline 715
- Primary DI
- 05707480158706
- Version / Model
- 71512-M/C/12
- Catalog Number
- 71512-M/C/12
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-03-11
- Public Version
- 3
- Public Version Date
- 2025-03-19
- Public Version Status
- Update
- Public Device Record Key
- 2b06a442-52a0-43a4-bd1b-5d7c4f974f43
Device Description
Neurology surface electrodes
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 61020 | Analytical non-scalp cutaneous electrode | An 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/from 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480158713 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 05707480158706 | GS1 | ||||
| Package | 05707480158720 | GS1 | Case | 8 | In Commercial Distribution | |
| Unit of Use | 05707480154913 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 120 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius