HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704717818
• Version / Model: IPN916689
• Catalog Number: RHUD59U
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-08-18
• Public Version: 1
• Public Version Date: 2020-08-26
• Public Version Status: New
• Public Device Record Key: 3f653040-a804-4a1c-a8f8-e75a1137d2f8

Device Description

ADDIPAK 0.9% NaCl for Inhalation USP, 5 mL

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: MR Unsafe
• 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: No
• 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
44746	Inhalation therapy saline solution, isotonic	A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34026704717812	GS1	Case	10	In Commercial Distribution
Primary	14026704717818	GS1
Unit of Use	44026704717819	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142153	000