FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Neuronaute Plus- Holding Band
DI: 03615220003983
·
Model: 1001-05001-UN
·
BIOSERENITY MEDICAL DEVICES GROUP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Neuronaute Plus- Holding Band
- Primary DI
- 03615220003983
- Version / Model
- 1001-05001-UN
- Company Name
- BIOSERENITY MEDICAL DEVICES GROUP
- Labeler DUNS
- 281224773
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-21
- Public Version
- 3
- Public Version Date
- 2025-01-23
- Public Version Status
- Update
- Public Device Record Key
- a38aa92b-f480-4980-b584-adbf50fadb87
- Distribution End Date
- 2025-01-21
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 35163 | Electroencephalographic ambulatory recorder | A portable electrically-powered device designed for recording of electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders; it is not intended for inpatient monitoring. It is a small unit designed to be worn by the patient with an appropriate signal amplifier, and intended to be used with a set of scalp electrodes that are placed on the cranium of the patient. The resulting electroencephalogram (EEG) data is analysed after the recording period using an appropriate computer/software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615220003983 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231366 | 000 |