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

GUDID 10376204300022

1 vial per pouch

RITEDOSE PHARMACEUTICALS, LLC

Inhalation therapy saline solution, isotonic

• Primary Device ID: 10376204300022
• NIH Device Record Key: 8d0e8a92-2e20-4ab4-9de5-085a3db24867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped
• Version Model Number: 3 mL
• Company DUNS: 968062294
• Company Name: RITEDOSE PHARMACEUTICALS, LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-806-3300
• Email: complaints@ritedose.com
• Phone: 1-855-806-3300
• Email: complaints@ritedose.com
• Phone: 1-855-806-3300
• Email: complaints@ritedose.com
• Phone: 1-855-806-3300
• Email: complaints@ritedose.com
• Phone: 1-855-806-3300
• Email: complaints@ritedose.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00376204300025 [Primary]
GS1	00376204300971 [Unit of Use]
GS1	10376204300022 [Package]; Contains: 00376204300025; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped]

• 00376204300018: One vial per foil pouch
• 10376204300022: 1 vial per pouch