HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 04026704389674
• Version / Model: IPN044382
• Catalog Number: 41095
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 2
• Public Version Date: 2020-01-31
• Public Version Status: Update
• Public Device Record Key: a98954e7-d7fe-4f22-bd23-54d12dd1348f

Device Description

Face Tent

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: Yes
• 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
12554	Aerosol tent, adult	A flexible enclosure designed for the top of a bed that is used to cover the head/torso of an adult patient to provide an aerosolized environment of breathing gases/vapours, e.g., a suspension of medicated liquid or solid particles, for medication therapy. It is typically used for the treatment of breathing disorders (e.g., asthma). It typically consists of a metal frame covered with transparent plastic, and wide bore tubing connected to the aerosol source. It is used to avoid direct attachment of the patient to a nasal cannula, face mask or endotracheal (ET) tube. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704389678	GS1	Case	50	Not in Commercial Distribution	2019-09-30
Primary	04026704389674	GS1

Customer Contacts

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