Vyaire 982082
GUDID 14250892906420
Adapter for saliva pump
Jaeger Medical GmbH
Cardiopulmonary stress exercise monitoring system| Primary Device ID | 14250892906420 |
| NIH Device Record Key | 5876b10a-727f-456a-8628-44ab10ba9acb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vyaire |
| Version Model Number | 982082 |
| Catalog Number | 982082 |
| Company DUNS | 329769991 |
| Company Name | Jaeger 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 | |
| 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 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14250892906420 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072323
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 | 2025-05-28 |
| Device Publish Date | 2023-01-03 |
On-Brand Devices [Vyaire]
| 14250892906451 | Flow Restrictor |
| 14250892906444 | Spare Screen PT 36 |
| 14250892906437 | Absorber |
| 14250892906420 | Adapter for saliva pump |
| 14250892906390 | Cross adapter |
| 14250892906383 | Cross Adapter |
| 14250892906376 | Cross adapter w. 3 ballon valve |
| 14250892906369 | Double tube adapter with In/Ex-valve |
| 14250892906352 | DVT Adapter w. salvia trap |
| 14250892906345 | Elbow 45°, ID 30 mm with connection nipple |
| 14250892906338 | Elbow piece 45° with luer connection |
| 14250892906321 | Flexible tube with elbow and extension |
| 14250892906314 | Light flexible tube with coupling and extension |
| 14250892906277 | Plug adapter |
| 14250892906260 | Shutter complete |
| 14250892906253 | Tube adapter with ballon valve |
Trademark Results [Vyaire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYAIRE 87121955 not registered Live/Pending |
VYAIRE MEDICAL, INC. 2016-07-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.