AirLife
GUDID 10190752196445
Sterile Water for Inhalation
VYAIRE MEDICAL, INC.
Inhalation therapy sterile water| Primary Device ID | 10190752196445 |
| NIH Device Record Key | 3b5a466a-fe17-450f-b75d-11f8f5cf5a5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AirLife |
| Version Model Number | 2D0735X |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | 1(833)327-3284 |
| customersupport@vyaire.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752196445 [Primary] |
| GS1 | 50190752196443 [Package] Package: Case [14 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090915
FDA Product Code
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2023-03-24 |
On-Brand Devices [AirLife]
| 50190752131062 | AirLife™ Volumetric Incentive Spirometer, 4000 ml |
| 50190752181203 | Infant Skin Temperature Probe, Single Patient Use |
| 10190752179622 | Infant Skin Temperature Probe, Reusable |
| 70190752179617 | Infant Skin Temperature Probe, Single Patient Use |
| 20190752179605 | Infant Skin Temperature Probe, Single Patient Use |
| 10190752196513 | Airlife™ Modudose™ Sterile Water for Inhalation, USP 5 ml |
| 10190752196506 | Airlife™ Modudose™ Sterile Water for Inhalation, USP 3 ml |
| 10190752196445 | Sterile Water for Inhalation |
| 10190752196438 | Sterile Water for inhalation |
| 10190752141803 | WATER STERILE IN HANGING BOTTLE 1000mL |
| 10190752141797 | WATER STERILE IN HANGING BOTTLE 2000mL |
| 10190752141773 | WATER STERILE FOR INHALATION 1000mL |
| 10190752117143 | Volumetric Incentive Spirometer |
| 10190752117129 | Volumetric Incentive Spirometer |
| 10190752154193 | CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD |
Trademark Results [AirLife]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AIRLIFE 97938590 not registered Live/Pending |
SunMed Group Holdings, LLC 2023-05-16 |
 AIRLIFE 97553332 not registered Live/Pending |
Hudson Brands, Inc. 2022-08-17 |
 AIRLIFE 86148589 not registered Dead/Abandoned |
Techtronic Floor Care Technology Limited 2013-12-19 |
 AIRLIFE 85669918 not registered Dead/Abandoned |
AIRLIFE CHILE S.A. 2012-07-06 |
 AIRLIFE 85253709 4335355 Dead/Cancelled |
AIRLIFE CHILE S.A. 2011-02-28 |
 AIRLIFE 79309660 not registered Live/Pending |
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI 2020-08-12 |
 AIRLIFE 79210163 not registered Dead/Abandoned |
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI 2016-10-18 |
 AIRLIFE 78545378 3150546 Live/Registered |
CAREFUSION 2200, INC. 2005-01-11 |
 AIRLIFE 78534814 3111371 Dead/Cancelled |
HENKEL AG & CO. KGAA 2004-12-17 |
 AIRLIFE 77830202 not registered Dead/Abandoned |
Hewlett-Packard Development Company, L.P. 2009-09-18 |
 AIRLIFE 75926229 not registered Dead/Abandoned |
AirSep Corporation 2000-02-23 |
 AIRLIFE 73353790 not registered Dead/Abandoned |
Insurance Concepts, Inc. 1982-03-10 |
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