Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1038185

FEI Number

1038185

Entity Name

COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.)

City/State/Country

WASHINGTON, NC, US

Establishment Address

209 Creekside Dr, WASHINGTON, NC 27889, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Coeur, Inc. (a wholly owned subsidiary of Illinois Tool Work (Owner Number: 9038672)

Owner / Operator Contact Address

209 Creekside Drive, Washington, NC 27889, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable 330psi Extension line w/ dual check valve Disposable 330psi Extension line DISP. TRANSFER SETS W-WO SWAB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2014-09-22
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-02-03
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2015-03-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-06-27
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-06-27
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-09-30

Official Correspondent

NEIL SPILLANE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Coeur, Inc. (a wholly owned subsidiary of Illinois Tool Work

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-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
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.

Similar Registrations

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1319639	Sterigenics U.S., LLC	Queensbury, NY, US
2520313	Bayer Medical Care Inc.	INDIANOLA, PA, US
3016096098	CENTERPIECE S. DE R.L DE C.V	Playas de Rosarito Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1038185. Last updated year: 2026. Please use registration number 1038185 when referencing this establishment in official correspondence.