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

GUDID 00376204300018

One vial per foil pouch

RITEDOSE PHARMACEUTICALS, LLC

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• Primary Device ID: 00376204300018
• NIH Device Record Key: 8afb098c-12aa-4ebc-bc36-6388695d9747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped
• Version Model Number: 5 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
• 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
• 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
• 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
• 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
• 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
• 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	00376204300018 [Primary]
GS1	00376204300964 [Unit of Use]
GS1	00376204300995 [Unit of Use]

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: 2021-09-07
• Device Publish Date: 2021-08-30

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