Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1417411

FEI Number

1417411

Entity Name

Medline Industries - Arlington Heights

City/State/Country

ARLINGTON HEIGHTS, IL, US

Establishment Address

900 W. University Drive,, ARLINGTON HEIGHTS, IL 60004, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993355

PMA Number

N/A

All Registered Proprietary Names

Hudson RCI Aquapak Nebulizer Aquapak Nebulizer; Aquapak Saline Reservoir; Aquapak Sterile Water Reservoir Antimicrobial Wound Lavage Medline Humidifier Nebulizer Kit Gibeck Humid-Flo and Passive Kits Aquapak Humidifier Reservoir with Adaptor ISO GARD Breathing Circuit Kit Hudson RCI Conventional Breathing Circuit with Filter Aquapak Nebulizer Reservoir with Adaptor Oxygen Therapy Start-Up Kit Hudson RCI Circuit / Column Kits Comfort Flo Humidification System Hudson RCI Conventional Breathing Circuit with Nebulizer Concha Nebulizer Concha Column ConchaPak Concha Column; Concha Reservoir; ConchaPak; ConchaTherm Brackets; ConchaTherm III; ConchaTherm Thermistor Probes Hudson RCI AddiPak Unit Dose Vial ConchaPak

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-08-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-08-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-07-17
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-07-17
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2016-06-03
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-08-23
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-08-23
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-08-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-01-08
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-08-23

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1417411. Last updated year: 2026. Please use registration number 1417411 when referencing this establishment in official correspondence.