FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Somnostar
DI: 10846446032550
·
Model: 28008-001
·
Carefusion Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Somnostar
- Primary DI
- 10846446032550
- Version / Model
- 28008-001
- Catalog Number
- 28008-001
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- 88e70163-a248-4090-b203-0c8f58ff6a61
- Distribution End Date
- 2022-03-31
Device Description
SWR KIT SSPRO SOFTWARE VER 11
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
- 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 |
|---|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10846446032550 | GS1 |
Customer Contacts
- Phone
- 800.231.2466
- [email protected]