Sodium Chloride Inhalation Solution, USP, 3%-4mL

GUDID 00370756663140

LIFESTAR PHARMA LLC

Inhalation therapy saline solution, hypertonic

• Primary Device ID: 00370756663140
• NIH Device Record Key: f380c73c-69a6-46f0-a32d-98e037a9ddb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Inhalation Solution, USP, 3%-4mL
• Version Model Number: 4mL
• Company DUNS: 080268943
• Company Name: LIFESTAR PHARMA LLC
• Device Count: 60
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.com
• Phone: 1-888-995-4337
• Email: ProductComplaintLifestar@mankindpharma.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370756663140 [Unit of Use]
GS1	00370756663607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232523

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: 2024-05-07
• Device Publish Date: 2024-04-29

Devices Manufactured by LIFESTAR PHARMA LLC

• 00370756661139 - Sodium Chloride Inhalation Solution, USP, 0.9%-3mL: 2024-05-07
• 00370756662150 - Sodium Chloride Inhalation Solution, USP, 0.9%-5mL: 2024-05-07
• 00370756663140 - Sodium Chloride Inhalation Solution, USP, 3%-4mL: 2024-05-07
• 00370756663140 - Sodium Chloride Inhalation Solution, USP, 3%-4mL: 2024-05-07
• 00370756664147 - Sodium Chloride Inhalation Solution, USP, 7%-4mL: 2024-05-07 Carton with 60 vials; 7% Sodium chloride inhalation solution, made to USP, 4mL vial, sterile, preservative free, non-pyrogenic.