FDA.reportPublic FDA data

AirLife™

Primary DI
10190752158450
Brand
AirLife™
Company
AIRLIFE
Model
CK0010
Catalog number
CK0010
Device description
Prefill Nebulizer Kit
Published
2021-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
50190752158458PackageGS112In Commercial Distribution
10190752158450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215845850190752158458
1019075215845010190752158450

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy sterile waterA quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344010486HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-10-31
10197344010370HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-10-17
10197344010394HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010462HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010479HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010493HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010912HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010943HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010967HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
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
10197344010752HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10197344010905HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10197344010950HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010759HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010902HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010957HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10889483598542AirLife™AIRLIFEOGG2025-03-07
10889483598573AirLife™AIRLIFEOGG2025-03-07
10889483598580AirLife™AIRLIFEOGG2025-03-07
30889483598546AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598577AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598584AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
10889483598559AirLife™AIRLIFEOGG2025-02-27
30889483598553AirLife™Sunmed Group Holdings, LLCOGG2025-02-27