| Z-2112-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX… | May 8, 2018 |
| Z-1911-2018 | Class II | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System… | Apr 25, 2018 |
| Z-1910-2018 | Class II | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400… | Apr 25, 2018 |
| Z-1909-2018 | Class II | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400… | Apr 25, 2018 |
| Z-1908-2018 | Class II | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix… | Apr 25, 2018 |
| Z-1926-2018 | Class II | Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended… | Apr 24, 2018 |
| Z-1925-2018 | Class II | Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended… | Apr 24, 2018 |
| Z-1924-2018 | Class II | Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended… | Apr 24, 2018 |
| Z-1923-2018 | Class II | Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended… | Apr 24, 2018 |
| Z-1922-2018 | Class II | Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended… | Apr 24, 2018 |
| Z-1667-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product… | Apr 3, 2018 |
| Z-1666-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product… | Apr 3, 2018 |
| Z-1665-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage… | Apr 3, 2018 |
| Z-1664-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage… | Apr 3, 2018 |
| Z-1663-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage… | Apr 3, 2018 |
| Z-0806-2018 | Class II | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105 | Feb 6, 2018 |
| Z-0411-2018 | Class II | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 | Dec 21, 2017 |
| D-0573-2018 | Class I | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter… | Nov 10, 2017 |
| Z-0971-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570)… | Oct 6, 2017 |
| D-0030-2018 | Class I | Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi… | Sep 15, 2017 |
| Z-3133-2017 | Class II | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | Sep 1, 2017 |
| Z-0485-2018 | Class II | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the… | Jul 27, 2017 |
| D-0973-2017 | Class II | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare… | Jul 6, 2017 |
| D-0972-2017 | Class II | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare… | Jul 6, 2017 |
| D-0957-2017 | Class II | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare… | Jul 6, 2017 |
| Z-3041-2017 | Class II | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice… | Jul 5, 2017 |
| Z-3040-2017 | Class II | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice… | Jul 5, 2017 |
| D-0789-2017 | Class II | Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag… | May 15, 2017 |
| D-0788-2017 | Class II | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx… | May 15, 2017 |
| Z-1280-2018 | Class II | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system… | Feb 15, 2017 |
| Z-1693-2017 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 | Jan 26, 2017 |
| Z-1095-2017 | Class II | Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used… | Jan 4, 2017 |
| Z-1094-2017 | Class II | Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used… | Jan 4, 2017 |
| Z-1056-2017 | Class II | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of… | Dec 16, 2016 |
| D-0425-2017 | Class II | 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare… | Dec 6, 2016 |
| D-0206-2017 | Class II | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx… | Dec 6, 2016 |
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product… | Oct 12, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump… | Sep 28, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product… | Sep 28, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product… | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6… | Jun 24, 2016 |
| Z-2049-2016 | Class II | PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy | May 23, 2016 |
| Z-1840-2016 | Class II | COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to… | May 12, 2016 |
| Z-1839-2016 | Class II | COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to… | May 12, 2016 |
| Z-1838-2016 | Class II | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to… | May 12, 2016 |
| Z-1631-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product… | Apr 21, 2016 |
| Z-1630-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage… | Apr 21, 2016 |
| Z-1629-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product… | Apr 21, 2016 |
| Z-1628-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product… | Apr 21, 2016 |
| Z-1627-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product… | Apr 21, 2016 |
| D-0852-2016 | Class II | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL… | Apr 12, 2016 |
| Z-1565-2016 | Class II | Automated peritoneal dialysis (APD) cycler | Feb 16, 2016 |
| D-0731-201 | Class II | 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation… | Feb 5, 2016 |
| D-0864-2016 | Class I | CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium)… | Jan 21, 2016 |
| D-0863-2016 | Class I | Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag… | Jan 21, 2016 |
| D-0862-2016 | Class I | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container… | Jan 21, 2016 |
| D-0861-2016 | Class II | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container… | Jan 21, 2016 |
| D-0958-2016 | Class I | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For… | Dec 15, 2015 |
| D-0957-2016 | Class I | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by… | Dec 15, 2015 |
| Z-0607-2016 | Class II | Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687… | Nov 30, 2015 |
| Z-0606-2016 | Class II | Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter… | Nov 30, 2015 |
| Z-0605-2016 | Class II | Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration… | Nov 30, 2015 |
| Z-0194-2016 | Class II | Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path | Oct 6, 2015 |
| D-1816-2015 | Class II | 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx… | Sep 2, 2015 |
| D-1336-2015 | Class I | 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter… | Jul 17, 2015 |
| D-1335-2015 | Class I | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container… | Jul 17, 2015 |
| D-1326-2015 | Class II | 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare… | Jul 2, 2015 |
| Z-0291-2016 | Class III | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis… | Jun 29, 2015 |
| D-1131-2015 | Class II | Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus… | Jun 3, 2015 |
| Z-0132-2016 | Class II | ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL… | May 21, 2015 |
| D-1211-2015 | Class I | Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare… | Mar 24, 2015 |
| D-1210-2015 | Class I | 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare… | Mar 24, 2015 |
| D-1209-2015 | Class I | 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare… | Mar 24, 2015 |
| D-1208-2015 | Class I | 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter… | Mar 24, 2015 |
| D-0429-2015 | Class II | 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter… | Mar 23, 2015 |
| D-0428-2015 | Class II | Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium)… | Mar 23, 2015 |
| D-0426-2015 | Class II | 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter… | Mar 18, 2015 |
| D-0425-2015 | Class II | 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by… | Mar 18, 2015 |
| Z-1451-2015 | Class II | Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum… | Mar 2, 2015 |
| Z-1269-2015 | Class II | MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. | Jan 22, 2015 |
| Z-1010-2015 | Class II | Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers… | Jan 14, 2015 |
| D-0380-2015 | Class II | Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag… | Dec 23, 2014 |
| Z-1039-2015 | Class II | Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product… | Dec 8, 2014 |
| D-481-2015 | Class I | 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare… | Dec 4, 2014 |
| D-0301-2015 | Class II | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium)… | Nov 25, 2014 |
| D-0256-2015 | Class II | Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only… | Nov 10, 2014 |
| D-0276-2015 | Class II | Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus… | Oct 30, 2014 |
| Z-1031-2015 | Class II | HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product… | Oct 21, 2014 |
| Z-0939-2015 | Class II | HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and… | Oct 6, 2014 |
| D-0004-2015 | Class II | DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC… | Sep 29, 2014 |
| Z-0085-2015 | Class I | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml… | Sep 16, 2014 |
| Z-0084-2015 | Class I | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture… | Sep 16, 2014 |
| D-1606-2014 | Class II | Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile… | Sep 8, 2014 |
| Z-2738-2014 | Class II | SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of… | Sep 3, 2014 |
| D-1610-2014 | Class I | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex… | Aug 7, 2014 |
| D-1542-2014 | Class II | ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter… | Aug 4, 2014 |
| D-1583-2014 | Class II | 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare… | Jul 30, 2014 |
| Z-2615-2014 | Class II | ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter… | Jul 14, 2014 |
| Z-2614-2014 | Class II | ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3… | Jul 14, 2014 |
| Z-2613-2014 | Class II | ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3… | Jul 14, 2014 |