Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Heated respiratory humidifier FDA UDI
Device Name: NEPTUNE HEATED HUMIDIFIER,CONCHASMART FDA UDI
Model / Reference: HUD42500 FDA UDI
Description: NEPTUNE HEATED HUMIDIFIER,CONCHASMART FDA UDI

Identifiers

Catalog Number: HUD42500 FDA UDI
Primary DI / UDI-DI: 10197344010806 FDA UDI
510(k) Number: K131912 FDA UDI
FDA Product Code: BTT FDA UDI
GMDN Term: Heated respiratory humidifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Heated respiratory humidifier

Hudson Rci by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heated respiratory humidifier.

Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
A Series Heated Humidifier — Respironics, Inc. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K131912 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI b298715e-c7ce-4341-8065-6c7a44e1ea8b 37 fields · synced May 29, 2026