FDA UDI
In Commercial Distribution
🇺🇸 United States
Polysmith Sleep System
DI: 00841983103131
·
Model: A/ONEBED-SCORE-9X
·
NIHON KOHDEN AMERICA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Polysmith Sleep System
- Primary DI
- 00841983103131
- Version / Model
- A/ONEBED-SCORE-9X
- Catalog Number
- A/ONEBED-SCORE-9X
- Company Name
- NIHON KOHDEN AMERICA, INC.
- Labeler DUNS
- 021063219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- 460a31c0-98bf-4cab-8eb3-3e541256062d
Device Description
Polysomnography Sleep System Version 9
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
- 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 |
|---|---|---|---|---|
| OLV | Standard polysomnograph with electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-normalizing quantitative electroencephalograph software | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42238 | Sleep disorder interpretive software | An interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking]. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841983103131 | GS1 |
Customer Contacts
- Phone
- +1(800)325-0283
- [email protected]