HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 10197344010806
• Version / Model: HUD42500
• Catalog Number: HUD42500
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-02
• Public Version: 2
• Public Version Date: 2024-07-30
• Public Version Status: Update
• Public Device Record Key: b298715e-c7ce-4341-8065-6c7a44e1ea8b

Device Description

NEPTUNE HEATED HUMIDIFIER,CONCHASMART

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: MR Unsafe
• 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
BTT	HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12050	Heated respiratory humidifier	A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10197344010806	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131912	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 94 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 20 – 26 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Keep Dry.