Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029706818

FEI Number

3029706818

Entity Name

RCI HUDSON DE MEXICO S. DE RL. DE CV.

City/State/Country

Nuevo Laredo Tamaulipas, MX

Establishment Address

Av. Industrias No. 5902, Building 2, Parque Industrial FINSA, Nuevo Laredo Tamaulipas 88275, MX

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

K220955

PMA Number

N/A

All Registered Proprietary Names

TurboMist Medline Hudson RCI Tee Adapter Medline Pressure Tubing and Accessories Medline Pressure Monitoring Tubing Medline Aerosol Tubing Dynacor Oxygen Connecting Tube Hudson RCI Oxygen Supply Tubing Connector Medline Christmas Tree Style Nut and Nipple Adapter Hudson RCI Comfort Flo CubCannula mBrace Endotracheal Tube Holder Medline Hudson RCI Face Tent Medline Tracheostomy Mask Medline Oxygen Mask Medline Hudson RCI High-Concentration Oxygen Masks Hudson RCI High Concentration Oxygen Mask Medline Adult Water Trap Medline Hudson Aerotee Model BERMAN AIRWAYS MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE DYNACOR AIRWAYS "Salt Airway S.A.L.T." VARIOUS SIZES DYNACOR AIRWAYS Medline Hard Guedel Airway Medline Airway Connector Bagging limb adaptor Hudson RCI Comfort Flo Plus Cannula Extra Small Hudson RCI Comfort Flo Nasal Cannula Premature Hudson RCI Comfort Flo Nasal Cannula Infant Medline Airway Connector Bagging limb adaptor Medline Oral Care Bite Block Hudson RCI Nasal Cannula Concha Column; Concha Reservoir; ConchaPak; ConchaTherm Brackets; ConchaTherm III; ConchaTherm Thermistor Probes Medline Hudson Side Draft Neb-U-Mist Nebulizer Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater HEATER, BREATHING SYSTEM W/WO CONTROLLER Medline Hudson Smooth-Flo Circuit NAMIC Fluid Delivery Set NAMIC Protection Station NAMIC Sosa Spike NAMIC Fluid Administration Set NAMIC Closed Fluid Systems NAMIC Filling Station NAMIC Filling Station Plus NAMIC Contrast Removal Valve NAMIC Protection Station Plus 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 Hudson RCI Triflo II Incentive Deep Breathing Exerciser Medline Hudson Low Concentration Oxygen Mask Medline Hudson Micro Mist Nebulizer Medline Hudson Neonatal Ventilator Circuit Hudson RCI Aquapak Nebulizer Hudson RCI Comfort Flo Medline Hudson RCI AquaPak Bubble Prefilled Humidifiers Aquapak Sterile Humidifier Reservoirs AquaPak Humidifier Adapters Humidifier Hudson RCI ConchaTherm Neptune Hudson RCI Comfort Flo Medline Breathing Circuit Medline Adult Expandable Anesthesia Circuit Aquapak Nebulizer; Aquapak Saline Reservoir; Aquapak Sterile Water Reservoir Hudson RCI

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	2024-01-11
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2006-04-11
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2009-01-16
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-01-08
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2024-02-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-01-16
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-06-23
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2009-01-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-07-25
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2022-04-27
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-02-01
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2009-01-16
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-07-18
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-06-24
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2009-01-16
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2022-06-08
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-06-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-06-23
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	1979-10-01
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	2022-06-23
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2022-08-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-07-25
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-01-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-06-23
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-06-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-04
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2016-06-03
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2022-11-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-06-23
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2009-01-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-07-25
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2022-07-25
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2022-07-25
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	2024-10-11
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	2023-12-06
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-06-23
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-04-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-01-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-08-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-10-05

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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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 3029706818. Last updated year: 2026. Please use registration number 3029706818 when referencing this establishment in official correspondence.