FDA.reportPublic FDA data

AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 15mL

Primary DI
30704411010313
Brand
AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 15mL
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
ASR0159
Device description
AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 15mL
Published
2019-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411010310PackageGS13In Commercial Distribution
30704411010313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441101031040704411010310
3070441101031330704411010313

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.

Regulatory Flags#

DUNS number
825673239
Device count
1
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
10704411017080AMSure ® Hydrophilic Latex Foley Catheters1AS41012HC2026-05-15
10704411017097AMSure ® Hydrophilic Latex Foley Catheters1AS41014HC2026-05-15
10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
10704411017189AMSure ® Hydrophilic Latex Foley Catheters1AS42022HC2026-05-15
10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752141766AirLife™AIRLIFECAF2021-04-02