Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Device Name: VENTILATOR CIRCUIT,10MM,DUAL HEATED LIMB FDA UDI
Model / Reference: IPN045228 FDA UDI
Description: VENTILATOR CIRCUIT,10MM,DUAL HEATED LIMB FDA UDI

Identifiers

Catalog Number: 780-42 FDA UDI
Primary DI / UDI-DI: 04026704598274 FDA UDI
510(k) Number: K010402 FDA UDI
FDA Product Code: BTT FDA UDI
GMDN Term: Ventilator breathing circuit, single-use 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

Yes

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 UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ventilator breathing circuit, single-use

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

Similar devices

Also classified as Ventilator breathing circuit, single-use.

MEDIFLEX — Mediflex Medikal · Class IIa
ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
AirLife™ — Airlife, Inc. · Class II
Classic RT — Plastiflex Group NV · Class I
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
AirLife™ — Airlife, Inc. · Class II

Cleared under the same submission

K010402 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 (1)

FDA UDI 18b4447d-2beb-426d-a801-cc7e96ea08bd 36 fields · synced May 30, 2026