Set, I.V. Fluid Transfer

FDA product code LHI · 197 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5440
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-12-30 – 2026-06-12

LHI 2001-06-25

INTER-VIAL

Applicant Duoject Medical Systems, Inc.

K number K010703

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LHI 2001-04-05

RECONSTITUTION KIT & VIAL CONNECTOR

Applicant Bioject, Inc.

K number K010623

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LHI 2001-03-28

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

Applicant Baxa Corp.

K number K002705

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LHI 2000-12-20

CHEMO-AIDE DISPENSING PIN

Applicant Baxter Healthcare Corp

K number K003730

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LHI 2000-07-11

NEEDLELESS TRANSFER DEVICE

Applicant Medimop Medical Projects, Ltd.

K number K001831

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LHI 2000-05-12

PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER

Applicant Carmel Pharma Ab.

K number K001368

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LHI 2000-05-05

MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE

Applicant Medimop Medical Projects, Ltd.

K number K001293

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LHI 2000-03-08

KAWASUMI LABORATORIES PHILEBOTOMY SET

Applicant Kawasumi Laboratories Co., Ltd.

K number K994323

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LHI 2000-02-29

SECURMIX

Applicant Eurospital

K number K000367

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LHI 1999-04-13

CODAN CHEMOSPIKE

Applicant Codan US Corp.

K number K990711

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LHI 1999-03-23

CHEMO MINI SPIKE PLUS

Applicant B. Braun of America, Inc.

K number K983794

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LHI 1998-04-17

IV DECANTER-FLEXIBLE

Applicant Inrad

K number K980587

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LHI 1998-03-03

PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO

Applicant Carmel Pharma Ab.

K number K980381

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LHI 1998-01-08

CHEMO-SPIKE II RECONSTITUTION DEVICE

Applicant Medi-Dose, Inc.

K number K974431

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LHI 1997-12-22

TAKY-SPIKE PLUS

Applicant Clinico

K number K974198

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LHI 1997-10-24

VIAL-MATE RECONSTITUTION DEVICE (2B8071)

Applicant Baxter Healthcare Corp

K number K973654

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LHI 1997-10-10

AUTOMIX 3+3/AS COMPOUNDER SYSTEM

Applicant Baxter Healthcare Corp

K number K961008

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LHI 1997-08-26

BAG DECANTER

Applicant Remington Medical, Inc.

K number K972134

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LHI 1997-08-26

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

Applicant Medical Specialty Innovations, Inc. (Msi)

K number K972117

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LHI 1997-05-06

AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;

Applicant Baxter Healthcare Corp

K number K955622

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LHI 1997-05-01

SAFE-CONNECT VIAL DISPENSING SPIKE

Applicant Faulding Medical Device Co.

K number K970789

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LHI 1997-04-02

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)

Applicant Critical Device Corp.

K number K964989

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LHI 1997-03-18

COMBIPROT EMERGENCY ENFUSION DEVICE

Applicant B.Braun Medical, Inc.

K number K970359

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LHI 1996-10-15

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

Applicant Bioject, Inc.

K number K963012

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LHI 1996-10-07

MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE

Applicant Medimop Medical Projects, Ltd.

K number K963583

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LHI 1996-05-29

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)

Applicant Abbott Laboratories

K number K960466

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LHI 1996-04-17

CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE

Applicant Codan Medlon, Inc.

K number K960921

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LHI 1996-04-04

FORMULATION PREPARATION DEVICE

Applicant B.Braun Medical, Inc.

K number K955398

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LHI 1996-03-06

SAFELINE MULTIDOSE VIAL ADAPTER

Applicant Mcgaw, Inc.

K number K955595

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LHI 1996-03-06

SAFELINE I.V. BAG ACCESS DEVICE

Applicant Mcgaw, Inc.

K number K955594

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LHI 1996-02-06

MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

Applicant Critical Device Corp.

K number K955896

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LHI 1995-10-13

QTMICRO(TM) SYSTEM

Applicant Q.I. Medical, Inc.

K number K950305

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LHI 1994-09-30

IV TRANSFER SPIKE

Applicant Migada, Ltd.

K number K943095

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LHI 1994-09-29

DISPENSING PIN WITH ONE-WAY VALVE

Applicant B. Braun of America, Inc.

K number K943181

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LHI 1994-04-04

TRANSFER SET

Applicant Puritas Health Care, Inc.

K number K935532

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LHI 1994-03-15

DIPRIVAN LUER CONNECTOR

Applicant Ohmeda Medical

K number K935274

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LHI 1994-02-14

ONCO-VIAL ADAPTER

Applicant David Bull Laboratories, USA, Inc.

K number K926071

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LHI 1993-09-15

VENTED NEEDLE

Applicant Excel Medical, Inc.

K number K932462

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LHI 1993-07-02

TRANSFER SET

Applicant Pacific Device, Inc.

K number K923782

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LHI 1993-06-18

SYRINGE ADAPTOR

Applicant Excel Medical, Inc.

K number K923966

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LHI 1993-04-21

INTERLINK UNIVERSAL VIAL ADAPTER

Applicant Baxter Healthcare Corp

K number K924064

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LHI 1993-03-03

IV FLUID TRANSFER PIN

Applicant B. Braun of America, Inc.

K number K925401

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LHI 1992-11-23

QUICKTEST SYSTEM

Applicant Q.I. Medical, Inc.

K number K920015

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LHI 1992-10-19

EDGE MEDICAL DISPENSING PIN

Applicant Edgewater Medical Center

K number K921031

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LHI 1992-06-30

NUTRIMIX MICROCOMPOUNDER

Applicant Abbott Laboratories

K number K921365

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LHI 1992-03-18

TRANSFER-AID(TM)

Applicant Healthtek, Inc.

K number K913985

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LHI 1992-02-14

ACACIAS PHARM/PUMP

Applicant Acacia, Inc.

K number K912771

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LHI 1992-02-11

EXCELSIOR SINGLE LEAD DISPENSING SET

Applicant Excel Medical, Inc.

K number K913804

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LHI 1991-05-09

GRAVITY PLUS CONTROLLER/COMPOUNDER

Applicant Fergy Corp.

K number K902853

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LHI 1991-04-25

PHARM-ASSIST

Applicant Excel Medical, Inc.

K number K905116

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LHI 1991-04-16

NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION

Applicant Abbott Laboratories

K number K910213

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LHI 1991-03-21

RECONSTITUTION DEVICE

Applicant Baxter Healthcare Corp

K number K910793

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LHI 1991-01-02

TPN FLUID TRANSFER SET

Applicant Mcgaw, Inc.

K number K905201

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LHI 1990-11-19

ADD-A-VIAL

Applicant Kendall Mcgaw Laboratories, Inc.

K number K904855

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LHI 1990-11-07

VALVE CONTROLLER FOR MICROMACRO COMPOUNDER

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

K number K903159

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LHI 1990-11-05

KWIKMIX

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

K number K904225

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LHI 1990-08-22

METRICARE EMPTY CONTAINER SYSTEMS

Applicant Metrix Co.

K number K895922

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LHI 1990-07-11

ADD-A-VIAL II BINARY CONNECTOR

Applicant Kendall Mcgaw Laboratories, Inc.

K number K900865

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LHI 1990-07-06

LUER LOCK TRANSFER PIN

Applicant Acacia, Inc.

K number K901063

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LHI 1990-07-02

VITALMIX (SET & BAG)

Applicant Pacific Device, Inc.

K number K902482

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LHI 1990-06-26

NUTRIMIX MACRO TPN COMPOUNDER

Applicant Abbott Laboratories

K number K901404

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LHI 1990-04-18

TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

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

K number K900585

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LHI 1990-03-23

PHARMULATOR

Applicant Acacia, Inc.

K number K896990

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LHI 1989-10-27

AUTOMIX COMPOUNDER Y - ADAPTOR SET

Applicant Stedim, Inc.

K number K890205

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LHI 1989-10-27

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR

Applicant Stedim, Inc.

K number K890204

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LHI 1989-10-06

AUTOMIX 3+3 COMPOUNDER

Applicant Baxter Healthcare Corp

K number K894827

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LHI 1988-11-22

MODIFIED SLIDING RECONSTITUTION DEVICE

Applicant Baxter Healthcare Corp

K number K884626

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LHI 1988-02-16

ADCOMP 4000 HP SYSTEM

Applicant Healthtek, Inc.

K number K874495

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LHI 1987-08-25

MODIFIED INSTAFIL

Applicant Instafil, Inc.

K number K872446

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LHI 1986-07-08

ADCOMP

Applicant Healthtek, Inc.

K number K860610

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LHI 1986-05-06

U - STAR (MICRO-STAR)

Applicant Corning Costar Corp.

K number K860703

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LHI 1986-05-01

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG

Applicant Churchill Corp.

K number K861434

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LHI 1986-04-07

TRANSFER SET

Applicant Migada, Ltd.

K number K860595

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LHI 1986-02-12

CHEMO-VENT

Applicant Intl. Medical Industries

K number K860434

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LHI 1986-02-12

DOUBLE-JECT TRANSFER NEEDLE

Applicant Medimix Products, Inc.

K number K860113

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LHI 1986-01-16

TRANSFER NEEDLE

Applicant Soma Intl., Inc.

K number K854556

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LHI 1985-11-13

STATLOCK

Applicant Healthtek, Inc.

K number K854008

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LHI 1985-11-06

SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST

Applicant Travenol Laboratories, S.A.

K number K853830

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LHI 1985-10-17

VIAL VENT FILTER

Applicant Baxter Healthcare Corp

K number K852467

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LHI 1985-10-16

MEDNOVA SAFETY BAG

Applicant Mednova Corp.

K number K853075

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LHI 1985-09-19

FLOW EASE(PLASTIC VENTED NEEDLE)

Applicant Acacia, Inc.

K number K853212

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LHI 1985-08-21

TRANSFER DEVICE

Applicant Advance Medical Designs, Inc.

K number K853188

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LHI 1985-08-16

MAXIFILL TRANSFER SET

Applicant Lyphomed, Inc.

K number K852882

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LHI 1985-04-04

TANDEM SETS I.V.

Applicant Acacia, Inc.

K number K850757

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LHI 1985-03-06

VERSA-FILL 120 & FILL SET 42-50

Applicant Intl. Medical Industries

K number K850051

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LHI 1985-02-22

CYTOSAFE NEEDLE

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

K number K844904

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LHI 1985-01-14

ADD-A-VIAL SOLUTION TRANSFER DEVICE

Applicant American Mcgaw

K number K843639

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LHI 1985-01-09

TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP

Applicant Travenol Laboratories, S.A.

K number K844340

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LHI 1984-08-17

MAXIFILL TRANSFER SET

Applicant Lyphomed, Inc.

K number K842345

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LHI 1984-02-17

SOLUTION TRANSFER SET

Applicant Berlex Laboratories, Inc.

K number K834500

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LHI 1983-09-12

TWOFER NEEDLE

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

K number K832347

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LHI 1983-09-12

VENTED I.V. TRANSFER NEEDLE

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

K number K832332

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LHI 1983-09-12

I.V. TRANSFER NEEDLE

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

K number K832312

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LHI 1983-04-18

Q.C. TESTER

Applicant Alltek Filtration, Inc.

K number K830836

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LHI 1983-04-12

DOUBLE LUMEN TRANSFER DEVICE

Applicant Codan Trading Co.

K number K830970

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LHI 1982-04-26

ACKRAD FLUID CONNECTING SET

Applicant Ackrad Laboratories

K number K820937

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LHI 1981-12-30

VACU-FIL TRANSFER SET

Applicant American Pharmaseal Div. Ahsc

K number K812928

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