Hudson Rci

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: ISO-NEB FILTERED NEBULIZER SYSTEM FDA UDI
Model / Reference: IPN914800 FDA UDI
Description: ISO-NEB FILTERED NEBULIZER SYSTEM FDA UDI

Identifiers

Catalog Number: 41755 FDA UDI
Primary DI / UDI-DI: 14026704670984 FDA UDI
510(k) Number: K895231 FDA UDI
FDA Product Code: CCQ FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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 UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Therapeutic agent nebulizer, benchtop

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

Similar devices

Also classified as Therapeutic agent nebulizer, benchtop.

InnoSpire Essence — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
Sidestream — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
AirLife™ — Airlife, Inc. · Class II
AirLife™ — VYAIRE MEDICAL, INC. · Class II
Salter AIRE Elite — SALTER LABS · Class II
InnoSpire Elegance — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
InnoSpire Mini — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
Sidestream — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II

Cleared under the same submission

K895231 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 6967894d-6e9e-46f3-94a9-97d4c402959b 36 fields · synced May 31, 2026