FDA.reportPublic FDA data

AirLife™

Primary DI
30889483598577
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
CK4505
Catalog number
CK4505
Device description
Prefill Nebulizer Kit
Published
2025-03-07
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
30889483598577PackageGS112In Commercial Distribution
10190752160194PreviousGS10
10889483598573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359857730889483598577
1019075216019410190752160194
1088948359857310889483598573

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
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
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

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
30889483598584AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
10889483598559AirLife™AIRLIFEOGG2025-02-27
30889483598553AirLife™Sunmed Group Holdings, LLCOGG2025-02-27
34026704659365HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16