NEXUS MEDICAL, LLC

FDA Device Registration & Listing · LENEXA, KS, US · Registration 3004194523

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004194523
FEI Number
3004194523
Entity Name
NEXUS MEDICAL, LLC
City/State/Country
LENEXA, KS, US
Establishment Address
11315 STRANG LINE ROAD, LENEXA, KS 66215, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
NEXUS MEDICAL, LLC (Owner Number: 9054517)
Owner / Operator Contact Address
11315 STRANG LINE ROAD, --, Lenexa, KS 66215, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K092418
PMA Number
N/A

All Registered Proprietary Names

Nexus TKO IV plus IV plus Nexus TKO Nexus TKO-6P IV Plus Nexus TKO-6 Nexus TKO IV Plus NexusTKO-4 Nexus TKO-4S Nexus NIS-5 IV Plus Nexus TKO IVplus NexusTKO-5 Nexus Cannula

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-03-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-04-26
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-06-21
KST System, Blood Collection, Vacuum-Assisted, Manual Hematology Class 1 864.9125 2015-05-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-05-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-09-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-05-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-02-12
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2010-02-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2010-02-12
HRX Arthroscope Orthopedic Class 2 888.1100 2007-05-24
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-05-24
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-08-21
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-04-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEXUS MEDICAL, 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
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
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

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
3018229072 INNOVATIVE HEALTH SCIENCES Chester, NY, US
3030989877 INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL Sun Valley, CA, US
1047843 ISOMEDIX OPERATIONS INC. SPARTANBURG, SC, US
3002807090 Sterigenics Germany GmbH Wiesbaden Hesse, DE
3013319212 ICU MEDICAL, INC. Lake Forest, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004194523. Last updated year: 2026. Please use registration number 3004194523 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.