Bellavista
GUDID 10190752188853
Diagnostic Package Capnography Mainstream
VYAIRE MEDICAL, INC.
Patient monitoring system module, carbon dioxide| Primary Device ID | 10190752188853 |
| NIH Device Record Key | aeaccea9-530a-4280-91d0-c55bc461fad8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bellavista |
| Version Model Number | 301.114.000 |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between 40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 200 KiloPascal and 1200 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752188853 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183364
FDA Product Code
| CBK | Ventilator, Continuous, Facility Use |
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 | 2024-01-10 |
| Device Publish Date | 2024-01-02 |
On-Brand Devices [Bellavista]
| 70190752148880 | Exhalation Valve |
| 50190752197709 | Adult and pediatric ventilator |
| 50190752197662 | Adult and pediatric ventilator |
| 10190752188921 | Diagnostic Package Capnography Sidestream |
| 10190752188853 | Diagnostic Package Capnography Mainstream |
Trademark Results [Bellavista]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BELLAVISTA 98412625 not registered Live/Pending |
Latii Inc. 2024-02-20 |
 BELLAVISTA 98202836 not registered Live/Pending |
pinklotusstore llc 2023-09-28 |
 BELLAVISTA 87285855 5270033 Live/Registered |
BellaVista Fruit, LLC 2016-12-30 |
 BELLAVISTA 87217797 5320972 Live/Registered |
Chief Industries, Inc. 2016-10-27 |
 BELLAVISTA 87217784 5320971 Live/Registered |
Chief Industries, Inc. 2016-10-27 |
 BELLAVISTA 79318833 not registered Live/Pending |
SHIMANO INC. 2021-07-05 |
 BELLAVISTA 79144819 not registered Dead/Abandoned |
CERAMICA DE BELLAVISTA, S.A. 2014-02-26 |
 BELLAVISTA 79054895 3744814 Dead/Cancelled |
imtmedical ag 2008-06-05 |
 BELLAVISTA 79045413 3505571 Dead/Cancelled |
TERRA MORETTI S.P.A. 2007-08-30 |
 BELLAVISTA 79037276 3480813 Live/Registered |
imtmedical ag 2007-03-01 |
 BELLAVISTA 77176728 not registered Dead/Abandoned |
Luna Carpet & Blinds Co., Inc. 2007-05-09 |
 BELLAVISTA 75858237 2410558 Live/Registered |
Chief Industries, Inc. 1999-11-26 |
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