Sodium Chloride Inhalation Solution, USP 7% 0487-9007-30

GUDID 30304879007308

NEPHRON PHARMACEUTICALS

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• Primary Device ID: 30304879007308
• NIH Device Record Key: 786b3f0e-239f-4945-bf36-fb7c4e0ba955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Inhalation Solution, USP 7%
• Version Model Number: 900730
• Catalog Number: 0487-9007-30
• Company DUNS: 079160190
• Company Name: NEPHRON PHARMACEUTICALS
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304879007307 [Primary]
GS1	10304879007304 [Package]; Contains: 00304879007307; Package: Case [30 Units]; In Commercial Distribution
GS1	30304879007308 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120051

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: 2024-03-07
• Device Publish Date: 2024-02-28

Devices Manufactured by NEPHRON PHARMACEUTICALS

• 30304879003300 - Sodium Chloride Inhalation Solution, USP 3%: 2024-03-07
• 30304879007308 - Sodium Chloride Inhalation Solution, USP 7%: 2024-03-07
• 30304879007308 - Sodium Chloride Inhalation Solution, USP 7%: 2024-03-07
• 30304879301031 - Sodium Chloride Inhalation Solution, USP 0.9%: 2024-03-07
• 30304879301338 - Sodium Chloride Inhalation Solution, USP 0.9%: 2024-03-07
• 30304879302014 - Sodium Chloride Inhalation Solution, USP 0.9%: 2024-03-07