FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV

Primary DI
00376204023603
Brand
Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV
Company
RITEDOSE PHARMACEUTICALS, LLC
Model
4 mL
Published
2022-01-11
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
K210126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210126000Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation2021-12-03CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00376204023603PrimaryGS10
00376204023955Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376204023603003762040236033762040236030376204023603
00376204023955003762040239553762040239550376204023955

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
1-855-806-3300complaints@ritedose.com

Regulatory Flags#

DUNS number
968062294
Device count
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00376204300025Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped3 mL2022-05-16
10376204300022Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped3 mL2022-05-16
00376204300018Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped5 mL2021-08-30
00376204020602Sodium Chloride Inhalation Solution, USP, 3.5% 4mL UDV4 mL2022-01-11
00376204021609Sodium Chloride Inhalation Solution, USP, 0.7% 4 mL UDV (UOU)4 mL2022-01-11
00376204022606Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV4 mL2022-01-11
00376204020954Sodium Chloride Inhalation Solution, USP, 3.5% 4mL UDV4 mL2022-01-11
00376204021951Sodium Chloride Inhalation Solution, USP, 0.7% 4 mL UDV (UOU)4 mL2022-01-11
00376204022958Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV4 mL2022-01-11
00376204023955Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV4 mL2022-01-11
00376204300032Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV3 mL2016-09-23
00376204300056Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV5 mL2016-09-23
00376204300506Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL UDV15 mL2016-09-23
00376204400039Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV 3 mL2017-03-08
00376204400053Sodium Chloride Inhalation Solution, USP, 0.45% 5 mL UDV5 mL2017-03-08
00376204500036Sterile Water for Inhalation, USP, 3 mL UDV3 mL2017-03-08
00376204500050Sterile Water for Inhalation, USP, 5 mL UDV 5 mL2017-03-08

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