FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuronaute 1.2 - High capacity battery module
DI: 03615220001729
·
Model: 1001-15016-UN
·
BIOSERENITY MEDICAL DEVICES GROUP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuronaute 1.2 - High capacity battery module
- Primary DI
- 03615220001729
- Version / Model
- 1001-15016-UN
- Company Name
- BIOSERENITY MEDICAL DEVICES GROUP
- Labeler DUNS
- 281224773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-12
- Public Version
- 2
- Public Version Date
- 2023-12-28
- Public Version Status
- Update
- Public Device Record Key
- d7384a71-c849-4b5c-87a9-9c0625ad275f
Device Description
The Neuronaute Battery High Capacity module is a removable, rechargeable electronic device. The battery is recharged using a charging station. It connects to the Neuronaute BioAdapter using 3 snap buttons located on its rear.
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38736 | Electroencephalographic monitoring system | An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615220001729 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202334 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius