Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Heated respiratory humidifier FDA UDI
Device Name: ConchaTherm Neptune, Dual Thermistor, pe FDA UDI
Model / Reference: IPN044323 FDA UDI
IPN924865 FDA UDI
Description: ConchaTherm Neptune, Dual Thermistor, pe FDA UDI

Identifiers

Catalog Number: 395-99 FDA UDI
Primary DI / UDI-DI: 04026704597796 FDA UDI
14026704734105 FDA UDI
510(k) Number: K063758 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

FDA UDIFDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Heated respiratory humidifier

Hudson Rci by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heated respiratory humidifier.

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Cleared under the same submission

K063758 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: Teleflex Incorporated

Sources (2)

FDA UDI 12ec1c1a-647e-496e-9203-5c5aab6d0ea2 36 fields · synced Jun 1, 2026
FDA UDI c29c269d-6806-434c-b63e-1df7d2b2f1ba 36 fields · synced May 27, 2026