FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Series
DI: 00851113007659
·
Model: XS10-4222
·
ADVANCED BRAIN MONITORING, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-Series
- Primary DI
- 00851113007659
- Version / Model
- XS10-4222
- Company Name
- ADVANCED BRAIN MONITORING, INC.
- Labeler DUNS
- 969842715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-25
- Public Version
- 4
- Public Version Date
- 2018-12-06
- Public Version Status
- Update
- Public Device Record Key
- 994e2af6-5520-459e-ba6b-d25dc6ac98c4
Device Description
Medium Strip Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37323 | Patient monitoring system module, electroencephalographic | A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851113007659 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131383 | 000 |