Icu Medical Costa Rica L T D

FDA Filings

This page includes the latest FDA filings for Icu Medical Costa Rica L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9615050
• FEI Number: 3002999813
• Name: ICU Medical Costa Rica Ltd.
• 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: 1 Km Noreste del Centro Comercial Real Cariari ZONA FRANCA GLOBAL Park; La Aurora de Heredia, -- CR
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Remanufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K133602 | LHI ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Two-Way Transfer Device	2018-04-16
PMN K171346 | MRZ ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Sapphire Set	2017-08-28
PMN K060806 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Gemstar Infusion Sets	2017-07-07
PMN K161469 | PHC ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-04-11
PMN K161469 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-04-11
PMN K161469 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-04-11
PMN K103344 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion Set	2017-02-21
PMN K103224 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion Set	2017-02-21
GBX ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Irrigation Set	2017-02-21
PMN K160492 | MRZ ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Sapphire Sets	2017-02-20
PMN K982159 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM A+ Infusion System	2017-02-17
PMN K952799 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM XL Infusion System	2017-02-17
PMN K941214 | FPK ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K911401 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Lifecare 5000 Infusion System	2017-02-17
PMN K844077 | KPE ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Nutrimix Empty Container	2017-02-17
PMN K791774 | KPE ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Empty Container and Infusion Set	2017-02-17
PMN K771228 | KPE ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Sterile Empty Container	2017-02-17
PMN K161036 | ODA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K161036 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K160870 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets	2017-02-17
PMN K151969 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K143612 | MEA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Lifecare PCA Infusion System	2017-02-17
PMN K143612 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Lifecare PCA Infusion System	2017-02-17
PMN K143087 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Blood Set	2017-02-17
PMN K143015 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Primary Set	2017-02-17
PMN K142974 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K142622 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Burette Set	2017-02-17
PMN K142433 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Extension Set	2017-02-17
PMN K142367 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Primary Set	2017-02-17
PMN K141834 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Administration Set	2017-02-17
PMN K141789 | PHC ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-02-17
PMN K141789 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-02-17
PMN K141789 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM 360 Infusion System	2017-02-17
PMN K141389 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Sapphire Sets	2017-02-17
PMN K123049 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion Pump System with Administration Set	2017-02-17
PMN K113683 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion Set	2017-02-17
PMN K110901 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion System	2017-02-17
PMN K110901 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion System	2017-02-17
PMN K101677 | FPA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Infusion Blood Set	2017-02-17
PMN K070398 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM A+ Infusion System	2017-02-17
PMN K052052 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM A+ Infusion System	2017-02-17
PMN K042800 | MEA ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	Lifecare PCA Infusion system	2017-02-17
PMN K042081 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM A+ Infusion System	2017-02-17
PMN K010924 | FRN ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	PLUM XL Infusion System	2017-02-17
BYY ICU Medical Costa Rica Ltd. [ICU MEDICAL, INC.]	THORACENTESIS SET, 30 Inch	2017-02-17

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092413048	Yantian,China (Mainland) -> Long Beach, California	AC POWER CORD	450 CTN
2020092266461	Caldera,Costa Rica -> Los Angeles, California	INFUSION PUMPS	20 PKG
2020091924337	Yantian,China (Mainland) -> Long Beach, California	AC POWER CORD	450 CTN
2020091148306	Yantian,China (Mainland) -> Long Beach, California	AC POWER CORD	450 CTN
2020090167306	Caldera,Costa Rica -> Los Angeles, California	INTRAVENOUS SETS	9 PKG
2020081842340	Caldera,Costa Rica -> Los Angeles, California	INFUSION PUMPS	6 PKG
2020081157049	Caldera,Costa Rica -> Los Angeles, California	INFUSION PUMPS	10 PKG
2020080431168	Caldera,Costa Rica -> Los Angeles, California	INFUSION PUMPS	9 PKG