Vyaire V-178501
GUDID 54250892904899
Vyntus WALK
Vyaire Medical GmbH
Stress exercise monitoring system computer| Primary Device ID | 54250892904899 |
| NIH Device Record Key | 1eab922f-5b3e-46a1-a7bb-bd02fe220438 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vyaire |
| Version Model Number | V-178501 |
| Catalog Number | V-178501 |
| Company DUNS | 329769991 |
| Company Name | Vyaire Medical GmbH |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com | |
| Phone | +499314972127 |
| support.rt.eu.jae@vyaire.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 54250892904899 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142959
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-03-19 |
On-Brand Devices [Vyaire]
| 04250892905600 | US Review Station SeS Win 10 |
| 04250892904764 | Vyntus CPX |
| 04250892904153 | Spirometry PC Software |
| 54250892905582 | Micro I |
| 54250892905575 | MicroLab |
| 54250892905568 | MicroLab |
| 54250892905551 | MicroLab |
| 54250892905544 | MicroDiary |
| 54250892905537 | PulmoLife |
| 54250892905520 | PulmoLife |
| 54250892905513 | PulmoLife |
| 54250892905506 | MicroCO |
| 54250892905490 | MicroRPM |
| 54250892905483 | MicroLoop |
| 54250892905476 | MicroLoop |
| 54250892905469 | MicroLoop |
| 54250892905452 | SpiroUSB |
| 54250892904899 | Vyntus WALK |
| 34250892904925 | Vyntus SPIRO |
| 34250892904918 | Vyntus SPIRO |
| 34250892904475 | MicroPeak |
| 34250892904468 | MicroPeak |
| 34250892904352 | Mouthpiece |
| 34250892904185 | Spirometry PC Software Update |
| 34250892904178 | Spirometry PC Software Licence |
| 34250892904161 | Spirometry PC Software |
| 34250892903461 | Rebreathing bag 20l |
| 34250892903430 | Vyntus Cart 3.1N 115V |
| 34250892903423 | Vyntus Cart 3.0N 115V |
| 34250892903409 | Vyntus Cart 3.1N 115V |
| 34250892903386 | Vyntus Cart 3.0 115V |
| 34250892903089 | MicroGard II, Filter Kit |
| 34250892903072 | MicroGard II, Filter Kit |
| 34250892903041 | MicroGard II, bacterial/viral filter |
| 34250892903034 | MicroGard II, bacterial/viral filter |
| 14250892904556 | Valve head for check valve with hole |
| 14250892904549 | Valve head for check valve |
| 14250892904525 | "Nebulizer kit SideStream incl.3 nebulizer" |
| 14250892904518 | "Pneumotach complete paediatric" |
| 14250892904501 | Dust filter for absorber |
| 14250892904495 | Nose clip pad |
| 14250892904488 | Rubber Flanged Mouthpiece |
| 14250892904402 | Rubber Flanged Mouthpiece |
| 14250892904341 | Turbine Complete |
| 14250892904334 | Turbine Complete |
| 14250892904303 | Volume Sensor insert |
| 14250892904297 | Volume Sensor insert Vyntus cpx |
| 14250892904280 | Elbow 45°, ID 30 mm |
| 14250892904273 | Elbow 45°, ID 30 mm, ULTEM, especially resistant against disinfection |
| 14250892904266 | Adapter, ID 30 mm to ID 30 mm |
Trademark Results [Vyaire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYAIRE 87121955 not registered Live/Pending |
VYAIRE MEDICAL, INC. 2016-07-30 |
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