PulmoSal 7% (pH+) 50190-740-60

GUDID 60850877007037

Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic

PHARMACARIBE, LLC.

Inhalation therapy saline solution, hypertonic

• Primary Device ID: 60850877007037
• NIH Device Record Key: 8dfc3710-fa57-44c4-9115-20b7da3cec28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PulmoSal 7% (pH+)
• Version Model Number: 74060
• Catalog Number: 50190-740-60
• Company DUNS: 011702541
• Company Name: PHARMACARIBE, 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: 804-339-4523
• Email: werner.gutmann@pharmacaribe.co
• Phone: 804-339-4523
• Email: werner.gutmann@pharmacaribe.co

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850877007035 [Unit of Use]
GS1	40850877007033 [Primary]
GS1	60850877007037 [Package]; Contains: 40850877007033; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130091

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

Devices Manufactured by PHARMACARIBE, LLC.

• 60850877007006 - NebuSal 3% USP: 2018-07-06 Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
• 60850877007013 - NebuSal 6% USP: 2018-07-06 Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
• 40850877007026 - Sodium Chloride Solution USP 7%: 2018-07-06 Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
• 60850877007037 - PulmoSal 7% (pH+): 2018-07-06Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic
• 60850877007037 - PulmoSal 7% (pH+): 2018-07-06 Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyro