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.
| 10190752187818 - iFlow | 2024-11-13 iFlow 200 S Adult/Pediatric Proximal Flow Sensor |
| 50190752187823 - iFlow | 2024-11-13 iFlow 40 S Neonatal/Infant Proximal Flow Sensor |
| 50190752200805 - LTV | 2024-11-13 Patient Circuit W/O PEEP, 15mm, SPU, Single Heated Wire, F&P |
| 50190752200829 - LTV | 2024-11-13 Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P |
| 10190752201019 - 3100 HFOV | 2024-11-13 Tube Set, Filtered Patient Circuit |
| 10190752201118 - LTV | 2024-11-13 Patient Circuit Ventilator Adapter |
| 50190752201536 - LTV | 2024-11-13 Patient Circuit, W/ PEEP, 15mm, SPU |
| 50190752200751 - LTV | 2024-08-21 Patient Circuit W/O PEEP, 22mm, SPU, Single Heated Wire, F&P |
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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