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

Matched from indexed company URL: Coeur, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10381851038185COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.)1N2026-01-01209 Creekside Dr WASHINGTON NC US 27889

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M297100600Coeur - 60 in. Coiled Line1-800-296-5893customer.service@coeurinc.com
M297100610Coeur - 60 in. Coiled Line with 1 Check Valve1-800-296-5893customer.service@coeurinc.com
M297101230Coeur - 4 in Extension Line with Check Valve and Male Luer with Rotating Skirt1-800-296-5893customer.service@coeurinc.com
M297722010Coeur - "MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96"" Y-Line, and 2 Spikes)"1-800-296-5893customer.service@coeurinc.com
M297722070Coeur - "MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 2-65mL Syringes, 1-96"" Y-Line and 2 Spikes)"1-800-296-5893customer.service@coeurinc.com
M297731020Coeur - " 200mL Single Syringe Kit for Stellant Injectors (Includes 1-200mL Syringes, 1-60"" Y-line, and 1 Spike"1-800-296-5893customerservice@coeurinc.com
M297732010Coeur - "200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60"" Y-line, and 2-Spikes"1-800-296-5893customer.service@coeurinc.com
M297732020Coeur - "200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60"" Y-line, 1 Contrast Spike, and 1-Saline Spike"1-800-296-5893customer.service@coeurinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
565501704564906K971712COEUR 130 ML ANGIOGRAPHIC SYRINGEDXT1997-10-08
565501278311411K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211DXT1996-09-12
565501229687065K942381LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBINGDXT1995-03-17
565501229135635K873597TUBING, POLYETHYLENEDXT1987-11-12
565501285426212K823920COEURLOCK STERILE DISPOS. ANGIOGRAPHICDXT1983-02-18
565502013284469K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram TipDXT2017-08-18
565501217058079K161471MR Syringe Dual Pack for Solaris InjectorsDXT2016-10-06
565501362985714K150902330psi Extension Y-Line with Dual Check ValveDXT2015-10-22
565501076585164K142745125mL CT SyringeDXT2015-04-01
565501157084037K140469MR SYRINGE DUAL PACKDXT2014-07-28
565501727650839K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTORDXT2014-04-30
565501299253651K120892DISPOSABLE 330PSI EXTENSION LINESDXT2013-06-10
565501156844257K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150DXT2009-10-19
565501581237058K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERSDQO2007-09-06
565501162585226K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORSDXT2007-10-04
565501915196408K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESFPK2007-02-09
565501438128642K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSDXT2005-11-02
565501794649330K032920THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003DXT2003-12-16
565501029127433
565501208258038
565501561490182
565501850870511

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXT162017-08-18
DQO12007-09-06
FPK12007-02-09

PMN#

GUDID#

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