Vyaire 706132
GUDID 14250892903511
Tube adapter with ballon valve
Vyaire Medical GmbH
Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult Pulmonary function analysis system, adult| Primary Device ID | 14250892903511 |
| NIH Device Record Key | 3ac70f4d-6636-40c3-9fa6-b91422a2b685 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vyaire |
| Version Model Number | 706132 |
| Catalog Number | 706132 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 |
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14250892903511 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122699
FDA Product Code
| BZC | Calculator, Pulmonary Function Data |
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 | 2019-06-12 |
| Device Publish Date | 2019-06-04 |
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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