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

Basic Information

• Brand Name: Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV
• Primary DI: 00376204023603
• Version / Model: 4 mL
• Company Name: RITEDOSE PHARMACEUTICALS, LLC
• Labeler DUNS: 968062294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2022-01-11
• Public Version: 1
• Public Version Date: 2022-01-19
• Public Version Status: New
• Public Device Record Key: 8d5938ef-19b7-4af9-bc00-759aada25eac

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58499	Inhalation therapy saline solution, hypertonic	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00376204023955	GS1
Primary	00376204023603	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210126	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit