Vyaire
GUDID 04057155000573
Mouthpiece, V-892894 repackaged for Clinical Trial use
eResearchTechnology GmbH
Breathing mouthpiece, single-use| Primary Device ID | 04057155000573 |
| NIH Device Record Key | 9e870537-d385-4759-8a25-cd7a3510227b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vyaire |
| Version Model Number | Mouthpiece, 30 pieces |
| Company DUNS | 341625331 |
| Company Name | eResearchTechnology GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@ert.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.com | |
| Phone | +4993057209891 |
| CustomerCare@clario.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 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 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 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 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 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 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 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 Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04057155000573 [Primary] |
FDA Product Code
| BYP | Mouthpiece, Breathing |
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 | 2020-03-23 |
| Device Publish Date | 2019-11-04 |
Devices Manufactured by eResearchTechnology GmbH
| 04057155000580 - SpiroSphere | 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG |
| 04057155000597 - SpiroSphere | 2024-07-30 Diagnostic device for ECG measurement and data collection |
| 04057155000665 - SpiroSphere | 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG |
| 04057155000672 - SpiroSphere | 2024-07-30 Diagnostic device for ECG measurement and data collection |
| 04057155000689 - SpiroSphere | 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG |
| 04057155000696 - SpiroSphere | 2024-07-30 Diagnostic device for ECG measurement and data collection |
| 04057155000795 - iSpiro Ultrasonic Sensor | 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters. |
| 04057155000818 - SpiroWay | 2024-07-30 Mouthpiece, accessory to spirometer |
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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