HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704648259
• Version / Model: IPN913903
• Catalog Number: 1098
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-09
• Public Version: 2
• Public Version Date: 2020-08-19
• Public Version Status: Update
• Public Device Record Key: 2260e9c5-e5de-4394-ad1f-e4d56f55e175

Device Description

ADULT SELECT-A-VENT™ Air Entrainment Mask Kit with Fixed Diluter

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
BYF	MASK, OXYGEN, LOW CONCENTRATION, VENTURI	Anesthesiology	868.5600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35175	Venturi oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704648256	GS1	Case	50	In Commercial Distribution
Primary	14026704648259	GS1
Previous	04026704594405	GS1

Customer Contacts

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