Hudson Rci

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: HUDSON RCI FDA UDI
Generic Name: Incentive spirometer FDA UDI
Device Name: INCENTIVE SPIROMETER,INTL FDA UDI
Model / Reference: IPN044469 FDA UDI
Description: INCENTIVE SPIROMETER,INTL FDA UDI

Identifiers

Catalog Number: 41750 FDA UDI
Primary DI / UDI-DI: 04026704390519 FDA UDI
510(k) Number: K781831 FDA UDI
FDA Product Code: BWF FDA UDI
GMDN Term: Incentive spirometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5690 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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Incentive spirometer

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

Similar devices

Also classified as Incentive spirometer.

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AincA® — Anesthesia Associates, Inc. · Class II
THRESHOLD — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
AirLife — Airlife, Inc. · Class II
AirLife™ — Airlife, Inc. · Class II
Portex — ICU MEDICAL, INC. · Class II

Cleared under the same submission

K781831 also covers:

HUDSON RCI — TELEFLEX INCORPORATED
HUDSON RCI — TELEFLEX INCORPORATED

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 c7647db8-c70e-4ee6-bdbc-c58ade1846df 36 fields · synced Jun 1, 2026