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Container, I.V.

FDA product code KPE · 117 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5025
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-30 – 2026-04-02

KPE 2026-04-02

Disposable Infusion Bag for Parenteral Nutrition

Applicant Beijing L&Z Medical Technology Development Co., Ltd.

K number K252079

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KPE 2026-03-20

ClaveQS™ Bag

Applicant Icu Medical, Inc.

K number K251980

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KPE 2026-01-09

KabiHelp® Uno; KabiHelp® Advance plus

Applicant Fresenius Kabi AG

K number K251139

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KPE 2025-08-01

eZSURE™ Empty Fluid Container

Applicant Epic Medical Pte. , Ltd.

K number K252094

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KPE 2025-04-18

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

Applicant Technoflex Sas.

K number K250459

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KPE 2024-06-21

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site

Applicant Epic Medical Pte. , Ltd.

K number K241442

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KPE 2023-09-01

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

Applicant Epic Medical Pte. , Ltd.

K number K223674

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KPE 2023-02-16

Disposable Infusion Bag for Parenteral Nutrition

Applicant Beijing L&Z Medical Technology Development Co., Ltd.

K number K222622

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KPE 2021-08-19

Empty EVA Bag

Applicant Haemotronic S.P.A.

K number K210749

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KPE 2021-05-06

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

Applicant Gilero, LLC

K number K201936

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KPE 2020-07-22

Empty EVA Bag

Applicant Haemotronic S.P.A.

K number K193528

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KPE 2019-08-15

HCT Empty EVA Container Pack

Applicant Health Care Technologies

K number K190328

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KPE 2019-04-30

Additive Cap

Applicant International Medical Industries, Inc.

K number K190305

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KPE 2019-02-15

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

Applicant Valmed S.R.L.

K number K181393

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KPE 2013-11-12

STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

Applicant Hospira, Inc.

K number K132276

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KPE 2012-07-13

EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER

Applicant Acta Medical, LLC

K number K121161

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KPE 2011-06-14

ADDITIVE CAP

Applicant Baxter Healthcare Corp

K number K111217

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KPE 2011-04-13

EVA TPN BAG

Applicant Valmed S.R.L.

K number K101412

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KPE 2009-01-30

ALL-IN-ONE CONTAINER

Applicant Baxter Healthcare Corporation

K number K090096

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KPE 2008-03-12

DUAL CHAMBER TPN CONTAINER

Applicant B.Braun Medical, Inc.

K number K073538

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KPE 2006-06-30

KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

Applicant Kawasumi Laboratories, Inc.

K number K061197

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KPE 2004-12-21

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

Applicant Churchill Medical Systems, Inc.

K number K041038

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KPE 2004-08-04

EVA TPN CONTAINER

Applicant B.Braun Medical, Inc.

K number K041415

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KPE 2003-12-30

GRI-BAG, GRI-BAG AP

Applicant Laboratorios Grifols, S.A.

K number K033916

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KPE 2003-11-24

GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML

Applicant Laboratorios Grifols, S.A.

K number K031419

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KPE 2003-04-02

EVA EMPTY SOLUTION CONTAINER

Applicant Metrix Co.

K number K030888

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KPE 2002-03-12

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML

Applicant Baxter Healthcare Corp

K number K020485

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KPE 2000-09-11

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

Applicant Biometrix , Ltd.

K number K001461

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KPE 2000-06-09

EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

Applicant Sorenson Medical, Inc.

K number K001287

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KPE 1998-11-03

ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712

Applicant Baxter Healthcare Corp

K number K983294

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KPE 1998-07-27

MPS RESERVOIR BAG

Applicant Medical Product Specialists

K number K982048

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KPE 1998-02-24

STERI-TAMP

Applicant Pharmacy, Inc.

K number K974180

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KPE 1997-11-24

CHARTERMED TPN-EVA BAGS

Applicant Chartermed, Inc.

K number K973103

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KPE 1997-11-05

VITALMIX PLUS EMPTY I.V. CONTAINER

Applicant Pacific Device, Inc.

K number K972464

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KPE 1997-03-31

INTRAVIA CONTAINER, EMPTY

Applicant Baxter Healthcare Corp

K number K964853

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KPE 1996-04-30

SECURE EVA DUAL CHAMBER MIXING BAG

Applicant Secure Medical Products, Inc.

K number K960581

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KPE 1995-05-12

ALL-IN-ONE TWO CHAMBER CONTAINER

Applicant Baxter Healthcare Corp

K number K945193

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KPE 1994-07-22

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET

Applicant Incutech, Inc.

K number K941731

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KPE 1994-06-10

UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET

Applicant Baxter Healthcare Corp

K number K932477

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KPE 1994-05-23

DISPOSABLE BAG DECANTER

Applicant Byron Medical

K number K934179

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KPE 1994-03-28

SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)

Applicant Incutech, Inc.

K number K940258

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KPE 1993-11-16

PHARMAFEED

Applicant Plasco, Inc.

K number K932649

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KPE 1993-11-10

EMPTY MIXING CONTAINER

Applicant Douglas Medical Products Corp.

K number K932641

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KPE 1993-11-10

EVA EMPTY MIXING CONTAINER

Applicant Douglas Medical Products Corp.

K number K932640

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KPE 1993-09-03

DUAL CHAMBER MIXING BAG

Applicant Secure Medical, Inc.

K number K926123

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KPE 1993-07-28

EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG

Applicant Healthtek, Inc.

K number K923448

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KPE 1993-03-26

EMPTY VIAFLEX PLASTIC CONTAINER

Applicant Baxter Healthcare Corp

K number K922214

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KPE 1991-11-29

SNAPPER

Applicant Healthtek, Inc.

K number K913608

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KPE 1991-08-02

DUAL COMPARTMENT TPN BAG 3 LITER

Applicant Stedim, Inc.

K number K911567

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KPE 1991-07-16

EMPTY I.V. CONTAINER

Applicant Ellis Pharmaceutical Consulting, Inc.

K number K910936

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KPE 1991-07-05

CHEMOTHERAPY CONTAINER

Applicant Bemis Mfg. Co.

K number K911576

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KPE 1991-04-24

BAG SPIGOT

Applicant Procedure Products, Inc.

K number K910673

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KPE 1990-10-29

ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION

Applicant Chartermed, Inc.

K number K902079

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KPE 1990-08-30

CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY

Applicant Chartermed, Inc.

K number K902464

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KPE 1990-07-26

METRICARE DRUG RESERVOIRS

Applicant Metrix Co.

K number K895924

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KPE 1989-12-01

OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE

Applicant Abbott Laboratories

K number K883400

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KPE 1989-06-07

MIX CONTAINER W/ATTACHED TRANSFER SET

Applicant Medical Support Systems

K number K885173

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KPE 1989-05-24

MEDIVERSE PARENTERAL NUTRITION BAG

Applicant Mediflex Intl.

K number K891077

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KPE 1989-05-24

PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET

Applicant Kells Medical, Inc.

K number K890095

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KPE 1989-05-24

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET

Applicant Kells Medical, Inc.

K number K890094

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KPE 1989-05-05

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION

Applicant Biomedical Dynamics, Inc.

K number K890268

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KPE 1989-03-14

BAG DECANTER

Applicant Superior Medical Products

K number K890272

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KPE 1988-05-20

MODIFIED EVA-MIX AND DI-MIX BAGS

Applicant Gil-Med Industries C/O Kegan & Kegan, Ltd.

K number K880506

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KPE 1988-02-16

60 ML RESERVOIR BAG, ITEM #200

Applicant Prn Services, Inc.

K number K875155

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KPE 1987-10-15

CHURCHILL PARENTERAL NUTRITION BAG - EVA

Applicant Churchill Corp.

K number K870395

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KPE 1987-06-17

ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG

Applicant Pa Medical Corp.

K number K871449

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KPE 1987-02-27

INFUMIX MIXING CONTAINER

Applicant Biodynamics Corp.

K number K870052

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KPE 1987-02-25

THERMAL JACKET FOR I.V. FLUID BAGS

Applicant Thermal Medical Systems, Inc.

K number K870113

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KPE 1987-02-10

DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER

Applicant Gil-Med Industries C/O Kegan & Kegan, Ltd.

K number K870274

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KPE 1986-10-31

DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS

Applicant Cher Mel Corp.

K number K863040

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KPE 1986-04-09

NUTRIMIX EMPTY CONTAINER

Applicant Abbott Laboratories

K number K860042

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KPE 1985-11-06

SNAP-LOCK ADDITIVE CAP #SL 300

Applicant Williams Medical Co.

K number K854034

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KPE 1985-11-06

SNAP-LOCK ADDITIVE CAP #SL400

Applicant Williams Medical Co.

K number K854033

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KPE 1985-11-06

SNAP-LOCK ADDITIVE CAP #SL100

Applicant Williams Medical Co.

K number K854031

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KPE 1985-11-01

SNAP-LOCK ADDITIVE CAP #SL 200

Applicant Williams Medical Co.

K number K854032

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KPE 1985-09-30

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK

Applicant Northern Customfab, Inc.

K number K852938

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KPE 1985-09-20

VIAL DECANTER

Applicant Advance Medical Designs, Inc.

K number K852893

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KPE 1985-08-16

BOTTLE DECANTER

Applicant Advance Medical Designs, Inc.

K number K852778

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KPE 1985-08-16

BAG DECANTER

Applicant Advance Medical Designs, Inc.

K number K852777

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KPE 1985-06-07

EMPTY SOLUTION TRANSFER CONTAINER

Applicant The Healthcare Group Laboratories, Inc.

K number K850035

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KPE 1985-05-06

THE I.V. BAG

Applicant Kabivitrum, Inc.

K number K844664

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KPE 1985-02-15

NUTRIMIX EMPTY CONTAINER

Applicant Abbott Laboratories

K number K844077

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KPE 1984-11-28

NUTRIBAG MIXING CONTAINER -2000 ML

Applicant Medical & Pharmaceutical Supplies, Inc.

K number K844410

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KPE 1984-11-28

MIXING CONTAINER

Applicant American Mcgaw

K number K843954

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KPE 1984-10-26

GIL-MED PARENTERAL NUTRITION OR MEDICINE

Applicant Gil-Med Industries C/O Kegan & Kegan, Ltd.

K number K841597

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KPE 1984-10-19

EMPTY SOLUTION TRANSFER CONTAINER

Applicant The Healthcare Group Laboratories, Inc.

K number K842170

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KPE 1984-10-16

EMPTY SOLUTION TRANSFER CONTAINER 1000

Applicant Polymer Technology Corp.

K number K843523

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KPE 1984-09-07

HOME NUTRIBAG MIXING CONTAINER 3000ML

Applicant Medical & Pharmaceutical Supplies, Inc.

K number K842629

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KPE 1984-09-07

HOME NUTRIBAG MIXING CONTAINER 1000ML

Applicant Medical & Pharmaceutical Supplies, Inc.

K number K842628

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KPE 1984-04-17

DIMIX CONTAINER FOR PARNETERAL NUTRIT

Applicant Gil-Med Industries C/O Kegan & Kegan, Ltd.

K number K840915

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KPE 1984-03-06

PAB IV CONTAINER

Applicant American Mcgaw

K number K840388

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KPE 1983-07-26

BAXA ADDISEAL

Applicant Baxa Corp., Sub. of Cook Group, Inc.

K number K832254

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KPE 1983-07-26

I.V. BAG ADDISEAL

Applicant Baxa Corp., Sub. of Cook Group, Inc.

K number K832247

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KPE 1983-03-09

CAT 3040

Applicant Burron Medical Products, Inc.

K number K830193

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KPE 1983-03-01

DELMED IV CONTAINER

Applicant Delmed, Inc.

K number K830450

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KPE 1983-02-19

SOLUTION TRANSFER CONTAINER

Applicant The Healthcare Group Laboratories, Inc.

K number K830299

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KPE 1983-02-09

DECANTER MODELS-VARIOUS

Applicant Steri-Sytems, Corp.

K number K830232

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KPE 1983-01-26

POUR BOTTLE DECANTER #2010

Applicant Medi-Plant Intl.

K number K823538

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KPE 1982-03-18

IV ALERT SYSTEM

Applicant Allied Medical Technologies, Inc.

K number K820200

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KPE 1982-03-08

BAXA ADDISEAL

Applicant Baxa Corp., Sub. of Cook Group, Inc.

K number K820435

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