FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP 0.9%

Primary DI
30304879301338
Brand
Sodium Chloride Inhalation Solution, USP 0.9%
Company
NEPHRON PHARMACEUTICALS
Model
930133
Catalog number
0487-9301-33
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

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
10304879301334PackageGS112In Commercial Distribution
00304879301337PrimaryGS10
30304879301338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030487930133410304879301334
00304879301337003048793013373048793013370304879301337
3030487930133830304879301338

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.

Sterilization Methods#

Method table
Method

Contacts#

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

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
30304879007308Sodium Chloride Inhalation Solution, USP 7%9007300487-9007-302024-02-28
30304879301031Sodium Chloride Inhalation Solution, USP 0.9%9301030487-9301-032024-02-28
30304879302014Sodium Chloride Inhalation Solution, USP 0.9%9302010487-9302-012024-02-28

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