FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 7%-4mL

Primary DI
00370756664604
Brand
Sodium Chloride Inhalation Solution, USP, 7%-4mL
Company
LIFESTAR PHARMA LLC
Model
4mL
Device description
Carton with 60 vials; 7% Sodium chloride inhalation solution, made to USP, 4mL vial, sterile, preservative free, non-pyrogenic.
Published
2024-04-29
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
K232523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232523000Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited2024-04-10CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00370756664604PrimaryGS10
00370756664147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370756664604003707566646043707566646040370756664604
00370756664147003707566641473707566641470370756664147

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-888-995-4337ProductComplaintLifestar@mankindpharma.com

Regulatory Flags#

DUNS number
080268943
Device count
60
DM exempt
true
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
00370756661993Sodium Chloride Inhalation Solution, USP, 0.9%-3mL3mL2024-04-29
00370756662990Sodium Chloride Inhalation Solution, USP, 0.9%-5mL5mL2024-04-29
00370756663607Sodium Chloride Inhalation Solution, USP, 3%-4mL4mL2024-04-29
00370756661139Sodium Chloride Inhalation Solution, USP, 0.9%-3mL3mL2024-04-29
00370756662150Sodium Chloride Inhalation Solution, USP, 0.9%-5mL5mL2024-04-29
00370756663140Sodium Chloride Inhalation Solution, USP, 3%-4mL4mL2024-04-29
00370756664147Sodium Chloride Inhalation Solution, USP, 7%-4mL4mL2024-04-29

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