ClearanceBrief
Panels › General Hospital › Product code LHI · Class 2

Set, I.V. Fluid Transfer

Regulation 880.5440

2510(k)s in 12 months (206 all time)
1recalls in 12 months (65 all time)
54recalls that name a 510(k)
Get daily alerts for LHISample briefCSV

Top companies in LHI

DateFirm and productCodeLinked 510(k)
Sep 17, 2026ICU Medical, Inc.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-2
Open, Classified
LHIK162219
Apr 4, 2025Omnicell, Inc.
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transf
Open, Classified
LHIK212530
Nov 1, 2024West Pharmaceutical Services AZ, Inc.
Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admix
Open, Classified
LHIK201415
Sep 19, 2024Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Open, Classified
LHIK002705
Sep 19, 2024Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Open, Classified
LHIK002705
Sep 19, 2024Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Open, Classified
LHIK002705
Sep 19, 2024Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Open, Classified
LHIK002705
Feb 16, 2024Baxter Healthcare Corporation
Baxter Exactamix Pro 2400, REF EXM24DY
Open, Classified
LHIK002705
Feb 16, 2024Baxter Healthcare Corporation
Baxter Exactamix Pro 1200, REF EXM12DY
Open, Classified
LHIK002705
Jan 7, 2023International Medical Industries, Inc.
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector,
Open, Classified
LHIK173577
Aug 24, 2022Baxter Healthcare Corporation
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. Thi
Open, Classified
LHIK002705
Jan 31, 2022B. Braun Medical, Inc.
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dos
Terminated
LHIK925401
K942988
Sep 18, 2019Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3
Terminated
LHIK900585
Jan 28, 2019WEST PHARMA. SERVICES IL, LTD
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Terminated
LHIK170095
Jan 28, 2019WEST PHARMA. SERVICES IL, LTD
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
Terminated
LHIK072759
Jan 28, 2019WEST PHARMA. SERVICES IL, LTD
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Terminated
LHIK170095
Apr 25, 2018Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound mult
Terminated
LHIK002705
Apr 25, 2018Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to
Terminated
LHIK002705
Apr 25, 2018Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to c
Terminated
LHIK002705
Apr 25, 2018Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the p
Terminated
LHIK002705
Oct 6, 2017Medimop Medical Projects Ltd.
Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatme
Terminated
LHIK140730
K170095
Oct 6, 2016Baxter Corporation Englewood
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Terminated
LHIK900585
Jun 2, 2016B. Braun Medical, Inc.
Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication
Terminated
LHIK943181
Jun 2, 2016B. Braun Medical, Inc.
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of trans
Terminated
LHIK943181
Jul 16, 2014Excelsior Medical Corp
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
Terminated
LHIK913804
Jul 1, 2014Baxter Healthcare Corp.
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR
Terminated
LHINone listed
Nov 27, 2013B. Braun Medical, Inc.
13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Terminated
LHIK090905
K900865 +1
Nov 27, 2013B. Braun Medical, Inc.
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Terminated
LHIK090905
K900865 +1
Nov 26, 2013Baxter Healthcare Corp.
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 1
Terminated
LHIK973654
Sep 6, 2013Baxa Corporation
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
Terminated
LHIK900585
Jul 18, 2013Baxa Corporation
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Terminated
LHIK002705
Apr 13, 2012Baxa Corporation
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
Terminated
LHIK900585
Sep 23, 2011Baxter Healthcare Corp.
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the p
Terminated
LHINone listed
May 25, 2011Baxter Healthcare Corp.
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the
Terminated
LHINone listed
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient t
Terminated
LHIK900585
Feb 22, 2011Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Co
Terminated
LHIK961008
Feb 22, 2011Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Com
Terminated
LHIK894827
Feb 22, 2011Baxter Healthcare Corp.
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder System
Terminated
LHINone listed
Feb 22, 2011Baxter Healthcare Corp.
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are
Terminated
LHINone listed
Nov 5, 2010B. Braun Medical Inc
B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution ba
Terminated
LHIK090905
Nov 5, 2010B. Braun Medical Inc
B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution ba
Terminated
LHIK090905
Mar 23, 2010Baxa Corporation
Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredi
Terminated
LHIK002705
May 6, 2009Migada Inc.
TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The devic
Terminated
LHIK051669
K071741
Aug 24, 2008Baxter Healthcare Corp.
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is i
Terminated
LHINone listed
Jul 30, 2008Smiths Medical Asd Inc
Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids.
Terminated
LHIK790314

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.