Vyntus 852828
GUDID 34250892901276
Rebreathing bag 20 L
Vyaire Medical GmbH
Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system| Primary Device ID | 34250892901276 |
| NIH Device Record Key | 1e0b04ef-25ad-42e6-8a0a-dc7491ec4d3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vyntus |
| Version Model Number | 852828 |
| Catalog Number | 852828 |
| 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
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 |
| 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 | 34250892901276 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-03-18 |
| Device Publish Date | 2018-07-31 |
On-Brand Devices [Vyntus]
| 04250892902661 | Vyntus ONE |
| 04250892902609 | Vyntus ONE |
| 04250892902593 | Vyntus ONE |
| 04250892902586 | Vyntus ONE |
| 04250892901084 | Vyntus ONE |
| 34250892902334 | Cart Vyntus 3.0 115V |
| 34250892902327 | Cart Vyntus 3.0 230V |
| 34250892901276 | Rebreathing bag 20 L |
| 14250892901487 | DVT complete |
| 14250892901449 | LED Holder |
| 14250892901432 | TwinTube collection tube |
| 14250892901326 | Plug-in |
| 14250892901319 | Canopy tube |
| 14250892901203 | DVT Adapter w. salvia trap |
Trademark Results [Vyntus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYNTUS 88623865 not registered Live/Pending |
Vyaire Medical, Inc. 2019-09-19 |
 VYNTUS 87002627 5184728 Live/Registered |
VYAIRE MEDICAL CAPITAL LLC 2016-04-15 |
 VYNTUS 85627210 not registered Dead/Abandoned |
CAREFUSION GERMANY 234 GMBH 2012-05-16 |
 VYNTUS 77211811 not registered Dead/Abandoned |
Viasys Holdings Inc. 2007-06-21 |
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