HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 10197344011629
• Version / Model: HUD05014
• Catalog Number: HUD05014
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-21
• Public Version: 1
• Public Version Date: 2026-01-29
• Public Version Status: New
• Public Device Record Key: 09945c93-7f97-42cd-a041-2656939c3968

Device Description

AQUATHERM III HEATER,ADJUST,LVN

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
CAF	Nebulizer (direct patient interface)	Anesthesiology	868.5630	2
BZE	HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER	Anesthesiology	868.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12716	Therapeutic agent vaporizer, benchtop	An assembly of devices intended to be used in the home and clinical settings to vaporize (through heating) 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 includes an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held inhalation compartment (e.g., inflatable balloon with mouthpiece).¿¿It is designed to be placed on a benchtop/flat surface during use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10197344011629	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223100	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 94 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry; Keep away from sunlight.
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius