FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV

Primary DI
00376204400039
Brand
Sodium Chloride Inhalation Solution, USP, 0.45% 3 mL UDV
Company
RITEDOSE PHARMACEUTICALS, LLC
Model
3 mL
Published
2017-03-08
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
00376204400039PrimaryGS10
00376204400985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376204400039003762044000393762044000390376204400039
00376204400985003762044009853762044009850376204400985

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
100
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
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
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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10197344042395HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
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00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
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