FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL UDV

Primary DI
00376204300506
Brand
Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL UDV
Company
RITEDOSE PHARMACEUTICALS, LLC
Model
15 mL
Published
2016-09-23
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
00376204300506PrimaryGS10
00376204300599Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376204300506003762043005063762043005060376204300506
00376204300599003762043005993762043005990376204300599

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
50
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109929Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-10-19
00848530109936Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-10-19
00812574027310CuraplexTRI-ANIM HEALTH SERVICES, INC.CAF2026-10-16
10197344042388HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
10197344042395HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
00848530109912Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-09-30
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30