FDA 510(k) Applications for Medical Device Product Code: KPE (Container, I.V.)

FDA 510(k) Applications for Medical Device Product Code "KPE"
(Container, I.V.)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K121161	ACTA MEDICAL LLC	EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER	07/13/2012
K073538	B. BRAUN MEDICAL, INC.	DUAL CHAMBER TPN CONTAINER	03/12/2008
K041415	B. BRAUN MEDICAL, INC.	EVA TPN CONTAINER	08/04/2004
K111217	BAXTER HEALTHCARE CORP.	ADDITIVE CAP	06/14/2011
K983294	BAXTER HEALTHCARE CORP.	ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712	11/03/1998
K020485	BAXTER HEALTHCARE CORP.	ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML	03/12/2002
K964853	BAXTER HEALTHCARE CORP.	INTRAVIA CONTAINER, EMPTY	03/31/1997
K090096	BAXTER HEALTHCARE CORPORATION	ALL-IN-ONE CONTAINER	01/30/2009
K222622	Beijing L&Z Medical Technology Development Co., Ltd.	Disposable Infusion Bag for Parenteral Nutrition	02/16/2023
K001461	BIOMETRIX LTD.	TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET	09/11/2000
K973103	CHARTERMED, INC.	CHARTERMED TPN-EVA BAGS	11/24/1997
K041038	CHURCHILL MEDICAL SYSTEMS, INC.	CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER	12/21/2004
K223674	Epic Medical Pte Ltd	eZSUREÖ Empty Fluid Container (models 426030, 426040, 426110)	09/01/2023
K201936	Gilero, LLC	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL	05/06/2021
K210749	Haemotronic S.p.a.	Empty EVA Bag	08/19/2021
K193528	Haemotronic, Spa	Empty EVA Bag	07/22/2020
K190328	Health Care Technologies	HCT Empty EVA Container Pack	08/15/2019
K132276	HOSPIRA, INC.	STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML	11/12/2013
K190305	International Medical Industries, Inc.	Additive Cap	04/30/2019
K061197	KAWASUMI LABORATORIES, INC.	KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER	06/30/2006
K033916	LABORATORIOS GRIFOLS, S.A.	GRI-BAG, GRI-BAG AP	12/30/2003
K031419	LABORATORIOS GRIFOLS, S.A.	GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML	11/24/2003
K982048	MEDICAL PRODUCT SPECIALISTS	MPS RESERVOIR BAG	07/27/1998
K030888	METRIX CO.	EVA EMPTY SOLUTION CONTAINER	04/02/2003
K972464	PACIFIC DEVICE, INC.	VITALMIX PLUS EMPTY I.V. CONTAINER	11/05/1997
K974180	PHARMACY, INC.	STERI-TAMP	02/24/1998
K960581	SECURE MEDICAL PRODUCTS, INC.	SECURE EVA DUAL CHAMBER MIXING BAG	04/30/1996
K001287	SORENSON MEDICAL, INC.	EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML	06/09/2000
K101412	VALMED S.R.L.	EVA TPN BAG	04/13/2011
K181393	VALMED SRL	Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP	02/15/2019

FDA 510(k) Applications for Medical Device Product Code "KPE" (Container, I.V.)

FDA 510(k) Applications for Medical Device Product Code "KPE"
(Container, I.V.)