FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 3% 15mL

Primary DI
00303786997893
Brand
Sodium Chloride Inhalation Solution, USP, 3% 15mL
Company
Mylan Pharmaceuticals Inc.
Model
15mL
Device description
The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials.Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Published
2016-12-12
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00303786997893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00303786997893003037869978933037869978930303786997893

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-446-3679customer.service@mylan.com

Regulatory Flags#

DUNS number
059295980
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303789300324Whisperject4005274604005274602018-03-19
00303786985012Sodium Chloride Inhalation Solution, USP, 0.9% 3mL UDV3mL2016-12-13
00303786986019Sodium Chloride Inhalation Solution, USP 0.9% 5mL5mL2016-12-13
00303786987894Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL15mL2016-12-12
00303786998890Sodium Chloride Inhalation Solution, USP 10% 15mL15mL2016-12-12

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