Sodium Chloride Solution USP 7% 50190-141-23

GUDID 40850877007026

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

PHARMACARIBE, LLC.

Inhalation therapy saline solution, hypertonic

• Primary Device ID: 40850877007026
• NIH Device Record Key: cc96dc2c-dcbf-4587-89ef-7dcf864bfb02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium Chloride Solution USP 7%
• Version Model Number: 14123
• Catalog Number: 50190-141-23
• 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	00850877007028 [Unit of Use]
GS1	40850877007026 [Primary]
GS1	60850877007020 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101424

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%: 2018-07-06Carton with 60 vials: 7% 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+): 2018-07-06 Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyro