SOMNOSTAR 28008-001
GUDID 10190752161993
SWR KIT SSPRO SOFTWARE VER 11
VYAIRE MEDICAL, INC.
Home-use sleep apnoea recording system| Primary Device ID | 10190752161993 |
| NIH Device Record Key | 8eb1dd39-7119-4cb1-af99-739bdda79ab7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOMNOSTAR |
| Version Model Number | 28008-001 |
| Catalog Number | 28008-001 |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752161993 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012085
FDA Product Code
| OLV | Standard polysomnograph with electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
Devices Manufactured by VYAIRE MEDICAL, INC.
| 10190752191518 - bellavista | 2025-08-05 bellaivsta Nurse Call Cable Normally Open |
| 10190752188860 - bellavista | 2025-08-04 bellaivsta Nurse Call Connector |
| 10190752191525 - bellavista | 2025-08-04 bellaivsta Nurse Call Connector |
| 10190752130364 - LTV2 Ventilator | 2025-07-24 TABLE STAND, LTV/LTV2 |
| 20190752201061 - 3100A HFOV | 2025-07-24 FILTER PK10 3100A |
| 10190752185197 - LTV2 | 2025-07-24 O2 CYLINDER MOUNT, LTV2 FLOOR STAND |
| 10190752188754 - LTV2 Ventilator | 2025-07-24 Nurse Call Cable, Normally Open |
| 10190752188761 - LTV2 Ventilator | 2025-07-24 Cable Assy, LTV2, Nurse Call N-C |
Trademark Results [SOMNOSTAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNOSTAR 75126859 2117557 Live/Registered |
SENSORMEDICS CORPORATION 1996-06-28 |
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