FDA UDI
In Commercial Distribution
🇺🇸 United States
Sleep Profiler PSG2
DI: 00851113007987
·
Model: SP29-1006.LE, SP29-1009.LE
·
ADVANCED BRAIN MONITORING, INC.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sleep Profiler PSG2
- Primary DI
- 00851113007987
- Version / Model
- SP29-1006.LE, SP29-1009.LE
- Company Name
- ADVANCED BRAIN MONITORING, INC.
- Labeler DUNS
- 969842715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-15
- Public Version
- 3
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 04b8618f-4e3d-4aef-a215-874df50e2e78
Device Description
Sleep Profiler PSG2 LE Device Kit - Piezo
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11467 | Electroencephalograph | An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included. | No | Active |
| 62230 | Home-use sleep apnoea recording system | A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00851113007949 | GS1 | ||||
| Primary | 00851113007987 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152040 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal