FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP 0.9%

Primary DI
00304879301030
Brand
Sodium Chloride Inhalation Solution, USP 0.9%
Company
NEPHRON PHARMACEUTICALS
Model
930103
Catalog number
0487-9301-03
Published
2024-02-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113033000SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3MLNephron Pharmaceuticals Corp.2012-06-19CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304879301037PackageGS18In Commercial Distribution
00304879301030PrimaryGS10
30304879301031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030487930103710304879301037
00304879301030003048793010303048793010300304879301030
3030487930103130304879301031

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-443-4313Customerservice@nephronpharm.com

Regulatory Flags#

DUNS number
079160190
Device count
100
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304879302013Sodium Chloride Inhalation Solution, USP 0.9%9302010487-9302-012024-02-28
00304879003309Sodium Chloride Inhalation Solution, USP 3%9003300487-9003-302024-02-28
00304879007307Sodium Chloride Inhalation Solution, USP 7%9007300487-9007-302024-02-28
00304879301337Sodium Chloride Inhalation Solution, USP 0.9%9301330487-9301-332024-02-28
30304879003300Sodium Chloride Inhalation Solution, USP 3%9003300487-9003-302024-02-28
30304879007308Sodium Chloride Inhalation Solution, USP 7%9007300487-9007-302024-02-28
30304879301031Sodium Chloride Inhalation Solution, USP 0.9%9301030487-9301-032024-02-28
30304879301338Sodium Chloride Inhalation Solution, USP 0.9%9301330487-9301-332024-02-28
30304879302014Sodium Chloride Inhalation Solution, USP 0.9%9302010487-9302-012024-02-28

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Primary DI, Brand, Company table
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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
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10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
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