FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP 7%

Primary DI
30304879007308
Brand
Sodium Chloride Inhalation Solution, USP 7%
Company
NEPHRON PHARMACEUTICALS
Model
900730
Catalog number
0487-9007-30
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120051000SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4MLNephron Pharmaceuticals Corp.2012-04-20CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304879007304PackageGS130In Commercial Distribution
00304879007307PrimaryGS10
30304879007308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030487900730410304879007304
00304879007307003048790073073048790073070304879007307
3030487900730830304879007308

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy saline solution, hypertonicA sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms, especially indicated for palliative treatment of cystic fibrosis (CF). It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079160190
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00304879301030Sodium Chloride Inhalation Solution, USP 0.9%9301030487-9301-032024-02-28
00304879301337Sodium Chloride Inhalation Solution, USP 0.9%9301330487-9301-332024-02-28
30304879003300Sodium Chloride Inhalation Solution, USP 3%9003300487-9003-302024-02-28
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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