FDA.reportPublic FDA data

Sterile Water for Inhalation, USP, 3 mL UDV

Primary DI
00376204500036
Brand
Sterile Water for Inhalation, USP, 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
00376204500036PrimaryGS10
00376204500982Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00376204500036003762045000363762045000360376204500036
00376204500982003762045009823762045009820376204500982

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy sterile waterA quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-506-3300complaints@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
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
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
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
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
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
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30