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

GUDID 00376204023955

RITEDOSE PHARMACEUTICALS, LLC

Inhalation therapy saline solution, hypertonic

• Primary Device ID: 00376204023955
• NIH Device Record Key: 8d5938ef-19b7-4af9-bc00-759aada25eac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV
• Version Model Number: 4 mL
• Company DUNS: 968062294
• Company Name: RITEDOSE PHARMACEUTICALS, LLC
• Device Count: 60
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00376204023603 [Primary]
GS1	00376204023955 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210126

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: 2022-01-19
• Device Publish Date: 2022-01-11

Devices Manufactured by RITEDOSE PHARMACEUTICALS, LLC

• 10376204300022 - Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped: 2022-05-24 1 vial per pouch
• 00376204020954 - Sodium Chloride Inhalation Solution, USP, 3.5% 4mL UDV: 2022-01-19
• 00376204021951 - Sodium Chloride Inhalation Solution, USP, 0.7% 4 mL UDV (UOU): 2022-01-19
• 00376204022958 - Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV: 2022-01-19
• 00376204023955 - Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV: 2022-01-19
• 00376204023955 - Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV: 2022-01-19
• 00376204300018 - Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped: 2021-09-07 One vial per foil pouch
• 00376204300032 - Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV: 2018-03-29
• 00376204300056 - Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV: 2018-03-29