NebuSal 6% USP

Basic Information

• Brand Name: NebuSal 6% USP
• Primary DI: 40850877007019
• Version / Model: 52323
• Catalog Number: 50190-523-23
• Company Name: PHARMACARIBE, LLC.
• Labeler DUNS: 011702541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ad9712ac-bf5d-4991-8b50-1b47712aee18

Device Description

Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58499	Inhalation therapy saline solution, hypertonic	A sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms, especially indicated for palliative treatment of cystic fibrosis (CF). It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60850877007013	GS1	Case	12	In Commercial Distribution
Primary	40850877007019	GS1
Unit of Use	00850877007011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101424	000

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit