HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704660787
• Version / Model: IPN049841
• Catalog Number: 048-91
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-08
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 1e02af48-e6ab-4eb3-8350-cdfb3161877c

Device Description

AQUATHERM HEATER 091

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZE	HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER	Anesthesiology	868.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12716	Benchtop nebulizer, heated	An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14026704660787	GS1
Previous	04026704597307	GS1
Direct Marking	24026704660784	GS1

Customer Contacts

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