Amy Giertych

FDA Filings

This page includes the latest FDA filings for Amy Giertych. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9617594
• FEI Number: 3003807466
• Name: Amy Giertych
• Owner & Operator: ICU MEDICAL, INC.
• Contact Address: 951 Calle Amanecer --; San Clemente CA 92673 US
• Official Correspondent:
  • Krishna Uppugonduri
  • x-949-3664366-x
• US Agent:
  • Amy Giertych
  • ICU MEDICAL, INC.
  • 224 7062344
  • amy.giertych@icumed.com
• Importing Logistics Registration:
  • Importer: Expeditors International of Washington Inc.
  • Address: 5395 Distriplex Farms Drive ; Memphis, TN 38141 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 600 N. Field Dr., ; Lake Forest, IL 60045 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K170110 | ONB Amy Giertych [ICU MEDICAL, INC.]	Diana ChemoLock Transfer Set	2019-02-21
PMN K173477 | ONB Amy Giertych [ICU MEDICAL, INC.]	ChemoCLAVE Prep System	2018-10-10
PMN K173477 | LHI Amy Giertych [ICU MEDICAL, INC.]	ChemoCLAVE Prep System	2018-10-10
PMN K173477 | FPA Amy Giertych [ICU MEDICAL, INC.]	ChemoCLAVE Prep System	2018-10-10
PMN K831506 | DRS Amy Giertych [ICU MEDICAL, INC.]	Disposable Transducer Monitoring Kits	2018-03-14
PMN K941214 | FPK Amy Giertych [ICU MEDICAL, INC.]	Extension Set	2017-02-17
FOX Amy Giertych [ICU MEDICAL, INC.]	Infusion Stand	2017-02-17
PMN K160374 | FOZ Amy Giertych [ICU MEDICAL, INC.]	NovaCath	2016-09-20
PMN K120839 | FOZ Amy Giertych [ICU MEDICAL, INC.]	NovaCath	2016-09-20
PMN K905116 | LHI Amy Giertych [ICU MEDICAL, INC.]	PharmAssist	2016-04-04
PMN K923966 | LHI Amy Giertych [ICU MEDICAL, INC.]	Syringe Adaptor	2016-03-01
PMN K913804 | LHI Amy Giertych [ICU MEDICAL, INC.]	Single Lead Dispensing Set	2016-03-01
PMN K140129 | DQE Amy Giertych [ICU MEDICAL, INC.]	PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter	2014-08-12
PMN K131549 | ONB Amy Giertych [ICU MEDICAL, INC.]	ChemoPort	2013-08-21
PMN K131549 | ONB Amy Giertych [ICU MEDICAL, INC.]	ChemoLock	2013-08-21
PMN K131549 | FPA Amy Giertych [ICU MEDICAL, INC.]	ChemoPort	2013-08-21
PMN K131549 | FPA Amy Giertych [ICU MEDICAL, INC.]	ChemoLock	2013-08-21
GCE Amy Giertych [ICU MEDICAL, INC.]	ADAPTOR, CATHETER	2013-08-09
PMN K884318 | KRB Amy Giertych [ICU MEDICAL, INC.]	Thermoset	2011-05-04
PMN K100576 | FPA Amy Giertych [ICU MEDICAL, INC.]	High Pressure Sets	2011-01-11
PMN K100434 | KGZ Amy Giertych [ICU MEDICAL, INC.]	Neutron	2010-07-16
PMN K100434 | FPA Amy Giertych [ICU MEDICAL, INC.]	Neutron	2010-07-16
PMN K941978 | DQO Amy Giertych [ICU MEDICAL, INC.]	High Pressure Tubing	2010-06-16
PMN K983559 | FJK Amy Giertych [ICU MEDICAL, INC.]	Bloof Tubing with Anti Regurgitation	2010-02-18
PMN K953573 | FMG Amy Giertych [ICU MEDICAL, INC.]	Stopcock Extension Sets	2010-02-18
PMN K941190 | FPA Amy Giertych [ICU MEDICAL, INC.]	IV Ext Set	2010-02-18
PMN K941190 | FPA Amy Giertych [ICU MEDICAL, INC.]	Ext Set	2010-02-18
PMN K941190 | FPA Amy Giertych [ICU MEDICAL, INC.]	Clave Ext Set	2010-02-18
PMN K941190 | FPA Amy Giertych [ICU MEDICAL, INC.]	CLAVE Extension Sets	2010-02-18
PMN K934591 | FMI Amy Giertych [ICU MEDICAL, INC.]	CLAVE Vial Access Spike	2010-02-18
PMN K932188 | KRA Amy Giertych [ICU MEDICAL, INC.]	Safeset	2010-02-18
PMN K932188 | DXN Amy Giertych [ICU MEDICAL, INC.]	Safeset	2010-02-18
PMN K932141 | DQO Amy Giertych [ICU MEDICAL, INC.]	Cardiac Catheterization Kit	2010-02-18
PMN K915171 | KNT Amy Giertych [ICU MEDICAL, INC.]	Lopez Valve	2010-02-18
PMN K914299 | DQO Amy Giertych [ICU MEDICAL, INC.]	Cardiac Catheterization Kit	2010-02-18
PMN K090189 | LHI Amy Giertych [ICU MEDICAL, INC.]	Antimicrobial CLAVE	2010-02-18
PMN K090189 | FPA Amy Giertych [ICU MEDICAL, INC.]	Antimicrobial CLAVE	2010-02-18
PMN K082836 | FMG Amy Giertych [ICU MEDICAL, INC.]	Universal Spikes	2010-02-18
PMN K082806 | FPA Amy Giertych [ICU MEDICAL, INC.]	Spinning Spiros	2010-02-18
PMN K052828 | DRS Amy Giertych [ICU MEDICAL, INC.]	Transpac IT	2010-02-15
PMN K061573 | DRS Amy Giertych [ICU MEDICAL, INC.]	Transpac IV	2010-02-07
PMN K061573 | DRS Amy Giertych [ICU MEDICAL, INC.]	Expressions MR	2010-02-07
PMN K941254 | DQO Amy Giertych [ICU MEDICAL, INC.]	Dye Management System	2008-10-24
PMN K052865 | DQO Amy Giertych [ICU MEDICAL, INC.]	Cath Lab Kits	2008-10-24
PMN K081361 | LHI Amy Giertych [ICU MEDICAL, INC.]	ChemoCLAVE Prep System	2008-09-22
PMN K081361 | FPA Amy Giertych [ICU MEDICAL, INC.]	ChemoCLAVE Prep System	2008-09-22
PMN K080989 | FMF Amy Giertych [ICU MEDICAL, INC.]	Universal Vial Access Spike	2008-09-22
PMN K080077 | LHI Amy Giertych [ICU MEDICAL, INC.]	CLAVE Stopcock	2008-09-22
PMN K080077 | FMG Amy Giertych [ICU MEDICAL, INC.]	CLAVE Stopcock	2008-09-22
PMN K080007 | KNY Amy Giertych [ICU MEDICAL, INC.]	Graduated Adapter With CLAVE	2008-09-22
PMN K080007 | EZD Amy Giertych [ICU MEDICAL, INC.]	Graduated Adapter With CLAVE	2008-09-22
PMN K070979 | KRA Amy Giertych [ICU MEDICAL, INC.]	Pull Tab Squeeze Flush	2008-09-22
PMN K070633 | FMF Amy Giertych [ICU MEDICAL, INC.]	Genie	2008-09-22
PMN K070532 | FPA Amy Giertych [ICU MEDICAL, INC.]	Spiros	2008-09-22
PMN K053106 | FPA Amy Giertych [ICU MEDICAL, INC.]	TEGO	2008-09-22
PMN K964435 | FMG Amy Giertych [ICU MEDICAL, INC.]	SetSource Ext Sets	2006-11-20
PMN K964435 | FMG Amy Giertych [ICU MEDICAL, INC.]	Primary IV Set	2006-11-20
PMN K934561 | FMF Amy Giertych [ICU MEDICAL, INC.]	Vial Access Spike	2006-11-20
PMN K974589 | FPA Amy Giertych [ICU MEDICAL, INC.]	Smartvalve	1999-08-04
PMN K970855 | FPA Amy Giertych [ICU MEDICAL, INC.]	CLAVE Connector	1999-08-04
PMN K954813 | FPA Amy Giertych [ICU MEDICAL, INC.]	Blood Banking Extension Sets	1999-08-04
PMN K940296 | FPA Amy Giertych [ICU MEDICAL, INC.]	Safe Connector	1999-08-04
PMN K915571 | FPA Amy Giertych [ICU MEDICAL, INC.]	CLAVE Connector	1999-08-04
PMN K910546 | FPA Amy Giertych [ICU MEDICAL, INC.]	Piggy Lock	1999-08-04

Similar & Related FDA Registered Companies

• ICU MEDICAL, INC.