Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010934635

FEI Number

3010934635

Entity Name

ECOMED SOLUTIONS, LLC

City/State/Country

Lindenhurst, IL, US

Establishment Address

2910 Falling Waters Blvd, Lindenhurst, IL 60046, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Ecomed Solutions, LLC (Owner Number: 10049951)

Owner / Operator Contact Address

2910 Falling Waters Blvd, Lindenhurst, IL 60046, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162088

PMA Number

N/A

All Registered Proprietary Names

Sureglide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2023-10-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-01-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-05
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2024-03-25
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2016-06-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2020-02-11
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-09-11
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-30

Official Correspondent

David Yurek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ecomed Solutions, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); 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.

Similar Registrations

Registration Number	Establishment Name	Location
3021187119	N8 MEDICAL LLC	Dublin, OH, US
3010400865	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
1420054	LSL HEALTHCARE	Niles, IL, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010934635. Last updated year: 2026. Please use registration number 3010934635 when referencing this establishment in official correspondence.