FDA UDI
In Commercial Distribution
🇺🇸 United States
Alice NightOne
DI: 00606959050877
·
Model: Alice NightOne, Korea
·
Respironics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alice NightOne
- Primary DI
- 00606959050877
- Version / Model
- Alice NightOne, Korea
- Catalog Number
- KR1114803
- Company Name
- Respironics, Inc.
- Labeler DUNS
- 080728314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-26
- Public Version
- 2
- Public Version Date
- 2021-03-04
- Public Version Status
- Update
- Public Device Record Key
- 3a4bb6bd-2715-4395-9a58-c802c028db83
Device Description
Alice NightOne, Korea
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MNR | Ventilatory effort recorder | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33843 | Polysomnograph | A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606959050877 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity