HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 24026704580471
• Version / Model: IPN045179
• Catalog Number: 7785
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 1
• Public Version Date: 2018-10-16
• Public Version Status: New
• Public Device Record Key: 3b849026-e10a-4e1b-b37f-342fbd863614

Device Description

Puritan Zep Mask Kit

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: Yes
• 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
BYG	MASK, OXYGEN	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35174	Partial-rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It includes a reservoir bag used for inhaling a mixture of exhaled and fresh gases. It is made of non-conductive, soft, flexible polymers available in a range of sizes, designed to create an airtight seal against the patient's face and may also include tubing, and various valves and connectors; other equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	24026704580471	GS1
Unit of Use	14026704580474	GS1

Customer Contacts

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