FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped

Primary DI
10376204300022
Brand
Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped
Company
RITEDOSE PHARMACEUTICALS, LLC
Model
3 mL
Device description
1 vial per pouch
Published
2022-05-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10376204300022PackageGS112In Commercial Distribution
00376204300025PrimaryGS10
00376204300971Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037620430002210376204300022
00376204300025003762043000253762043000250376204300025
00376204300971003762043009713762043009710376204300971

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.

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

Regulatory Flags#

DUNS number
968062294
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00376204300025Sodium 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
00376204023603Sodium Chloride Inhalation Solution, USP, 10% 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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