FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Series, X8
DI: 00851113007161
·
Model: UN03-4004
·
ADVANCED BRAIN MONITORING, INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-Series, X8
- Primary DI
- 00851113007161
- Version / Model
- UN03-4004
- Company Name
- ADVANCED BRAIN MONITORING, INC.
- Labeler DUNS
- 969842715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 3a340da9-ab77-470a-b904-0251830cee7e
Device Description
Dual Lead Cable 20" Kit
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35750 | Analytical non-scalp cutaneous lead | An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device. | No | Active |
| 35562 | Electrocardiographic lead set, reusable | A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851113007161 | GS1 |