FDA.reportPublic FDA data

AirLife™

Primary DI
50190752160192
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
CK4505
Catalog number
CK4505
Device description
Prefill Nebulizer Kit
Published
2021-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGGHumidifier nebulizer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752160192PackageGS112In Commercial Distribution
10190752160194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075216019250190752160192
1019075216019410190752160194

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy saline solution, isotonicA sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752190535LTV10611106112025-08-26
10190752191518bellavista301.115.010301.115.0102025-07-28
10190752188860bellavista301.115.000301.115.0002025-07-25
10190752191525bellavista301.115.020301.115.0202025-07-25
10190752130364LTV2 Ventilator30509-00130509-0012025-07-16
201907522010613100A HFOV7671637671632025-07-16
10190752185197LTV228774-00128774-0012025-07-16
10190752188754LTV2 Ventilator24425-00124425-0012025-07-16
10190752188761LTV2 Ventilator24426-00124426-0012025-07-16
10190752188808LTV2 Ventilator30512-00130512-0012025-07-16
10190752190368LTV2 Ventilator29242-00129242-0012025-07-16
10190752187818iFlow301.328.020301.328.0202024-11-05
50190752187823iFlow301.328.020301.328.0202024-11-05
50190752200805LTV29660-00129660-0012024-11-05
50190752200829LTV29701-00129701-0012024-11-05
101907522010193100 HFOV11438-PMN11438-PMN2024-11-05
10190752201118LTV10696106962024-11-05
50190752201536LTV11872x1011872x102024-11-05
50190752200751LTV29659-00129659-0012024-08-13
10190752201446LTV15091-10215091-1022024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344010391HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010469HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010476HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010490HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010919HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010940HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010964HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010759HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010902HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010957HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
30889483598546AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598577AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598584AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598553AirLife™Sunmed Group Holdings, LLCOGG2025-02-27
44026704659362HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16
44026704659379HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16
40193489423830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGG2022-01-02
50190752158489AirLife™VYAIRE MEDICAL, INC.OGG2021-04-19
50190752152098AirLife™VYAIRE MEDICAL, INC.OGG2021-03-26
50190752158458AirLife™VYAIRE MEDICAL, INC.OGG2021-03-26
50190752156669AirLife™VYAIRE MEDICAL, INC.OGG2021-03-19
24026704717761HUDSON RCITELEFLEX INCORPORATEDOGG2020-08-18
16971331400320YirdocQingdao Future Medical Technology Co., Ltd.OGG2020-06-22
10709078007788Composite Respiratory KitWESTMED, INC.OGG2019-10-18
34026704627869HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
34026704627951HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
34026704627975HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
14026704627988HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07
14026704628466HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07
14026704628473HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07