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)
Top companies in LHI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2026 | ICU 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 |
LHI | K162219 |
| Apr 4, 2025 | Omnicell, 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 |
LHI | K212530 |
| Nov 1, 2024 | West 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 |
LHI | K201415 |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device Open, Classified |
LHI | K002705 |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device Open, Classified |
LHI | K002705 |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device Open, Classified |
LHI | K002705 |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device Open, Classified |
LHI | K002705 |
| Feb 16, 2024 | Baxter Healthcare Corporation Baxter Exactamix Pro 2400, REF EXM24DY Open, Classified |
LHI | K002705 |
| Feb 16, 2024 | Baxter Healthcare Corporation Baxter Exactamix Pro 1200, REF EXM12DY Open, Classified |
LHI | K002705 |
| Jan 7, 2023 | International 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 |
LHI | K173577 |
| Aug 24, 2022 | Baxter 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 |
LHI | K002705 |
| Jan 31, 2022 | B. 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 |
LHI | K925401 K942988 |
| Sep 18, 2019 | Baxter 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 |
LHI | K900585 |
| Jan 28, 2019 | WEST PHARMA. SERVICES IL, LTD Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only Terminated |
LHI | K170095 |
| Jan 28, 2019 | WEST PHARMA. SERVICES IL, LTD Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only Terminated |
LHI | K072759 |
| Jan 28, 2019 | WEST PHARMA. SERVICES IL, LTD Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only Terminated |
LHI | K170095 |
| Apr 25, 2018 | Baxter 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 |
LHI | K002705 |
| Apr 25, 2018 | Baxter 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 |
LHI | K002705 |
| Apr 25, 2018 | Baxter 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 |
LHI | K002705 |
| Apr 25, 2018 | Baxter 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 |
LHI | K002705 |
| Oct 6, 2017 | Medimop 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 |
LHI | K140730 K170095 |
| Oct 6, 2016 | Baxter 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 |
LHI | K900585 |
| Jun 2, 2016 | B. 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 |
LHI | K943181 |
| Jun 2, 2016 | B. 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 |
LHI | K943181 |
| Jul 16, 2014 | Excelsior 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 |
LHI | K913804 |
| Jul 1, 2014 | Baxter 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 |
LHI | None listed |
| Nov 27, 2013 | B. 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 |
LHI | K090905 K900865 +1 |
| Nov 27, 2013 | B. 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 |
LHI | K090905 K900865 +1 |
| Nov 26, 2013 | Baxter 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 |
LHI | K973654 |
| Sep 6, 2013 | Baxa 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 |
LHI | K900585 |
| Jul 18, 2013 | Baxa Corporation ExactaMix 1200 and 2400 Compounders.
Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. Terminated |
LHI | K002705 |
| Apr 13, 2012 | Baxa 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 |
LHI | K900585 |
| Sep 23, 2011 | Baxter 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 |
LHI | None listed |
| May 25, 2011 | Baxter 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 |
LHI | None listed |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Feb 22, 2011 | Baxter 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 |
LHI | K961008 |
| Feb 22, 2011 | Baxter 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 |
LHI | K894827 |
| Feb 22, 2011 | Baxter 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 |
LHI | None listed |
| Feb 22, 2011 | Baxter 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 |
LHI | None listed |
| Nov 5, 2010 | B. 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 |
LHI | K090905 |
| Nov 5, 2010 | B. 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 |
LHI | K090905 |
| Mar 23, 2010 | Baxa 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 |
LHI | K002705 |
| May 6, 2009 | Migada 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 |
LHI | K051669 K071741 |
| Aug 24, 2008 | Baxter 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 |
LHI | None listed |
| Jul 30, 2008 | Smiths 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 |
LHI | K790314 |
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