Somnostar
CAREFUSION,THERMOCOUPLE (ADULT) - This GTIN is not associated with the marketed product
1manufacturer
28catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Carefusion, United States |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K012085 |
| Record published | 2016-09-13 |
| Record revised | 2024-06-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2022-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28477-001 | Withdrawn | |
| 63734 | Withdrawn | |
| 69329 | Withdrawn | |
| 776612 | Withdrawn | |
| 28482-001 | Withdrawn | |
| 28009-001 | Withdrawn | |
| 28484-001 | Withdrawn | |
| 23586-001 | Withdrawn | |
| 30862-001 | Withdrawn | |
| 63783 | Withdrawn | |
| 23474-001 | Withdrawn | |
| 16955 | Withdrawn | |
| 28483-001 | Withdrawn | |
| 28481-001 | Withdrawn | |
| 16610 | Withdrawn | |
| 23469-001 | Withdrawn | |
| 27188-001 | Withdrawn | |
| 23486-001 | Withdrawn | |
| 29675-001 | Withdrawn | |
| 27686-001 | Withdrawn | |
| 26322-001 | Withdrawn | |
| 31759-001 | Withdrawn | |
| 16623 | Withdrawn | |
| 27187-001 | Withdrawn | |
| 11626 | Withdrawn | |
| 28008-001 | Withdrawn | |
| 22312-001 | Withdrawn | |
| 16954 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alice 6 | Respironics Inc. | 58 |
| Standard Polysomnograph With Electroencephalograph | Nihon Kohden America, Inc. | 18 |
| Standard Polysomnograph With Electroencephalograph | Nihon Kohden Corp. | 17 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 10 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 8 |
| Trackit Sleepwalker | Lifelines Ltd. | 8 |
| micromed | Micromed, Inc. | 7 |
| Compumedics Grael | Compumedics Limited | 6 |
| Neurovirtual | Neurovirtual USA, Inc. | 4 |
| Pro-Flow | Respironics Inc. | 3 |
| Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m | Neurotronics, LLC | 3 |
| Xltek | Embla Systems | 3 |
Showing 12 of 89. All products under Standard Polysomnograph With Electroencephalograph
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.