FDA 510(k) Applications for Medical Device Product Code "MRZ"
(Accessories, Pump, Infusion)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K083221 | AIDERA AB | AIDERA DIASEND | 02/03/2009 |
| K101806 | AIDERA AB | AIDERA DIASEND SYSTEM | 12/07/2010 |
| K971213 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P | 05/27/1997 |
| K971212 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 | 05/27/1997 |
| K972780 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | 10/20/1997 |
| K971237 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 | 05/27/1997 |
| K971234 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 | 05/27/1997 |
| K972089 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 | 07/03/1997 |
| K972779 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | 10/20/1997 |
| K970786 | ALEXANDER MFG. CO. | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) | 05/27/1997 |
| K142333 | AMERICAN I.V. PRODUCTS, INC dba AIV, INC | SMART LABEL, PROPOFOL | 12/18/2014 |
| K120209 | AMERICAN I.V. PRODUCTS, INC. | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | 04/12/2012 |
| K080587 | ANIMAS CORP. | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | 05/15/2008 |
| K023890 | APPRO HEALTHCARE, INC. | PREPARE CARTRIDGE | 02/07/2003 |
| K173531 | B. Braun Medical Inc. | Lockbox for Perfusor Space PCA Infusion Pump | 08/02/2018 |
| K191910 | B. Braun Melsugen AG | SpaceStation MRI | 03/12/2020 |
| K201634 | Chengdu Shifeng Medical Technology Co., Ltd. | RG 3ml Medication Cartridge | 03/26/2021 |
| K980165 | DATREND SYSTEMS, INC. | INFUTEST 2000 INFUSION DEVICE ANALYZER | 04/20/1998 |
| K220695 | Elite Biomedical Solutions | Elite Biomedical Solutions Dose Request Cord | 04/29/2022 |
| K962159 | FAULDING MEDICAL DEVICE CO. | STERILE AMBULATORY RESERVOIR 60ML/100ML | 07/18/1997 |
| K990091 | FAULDING PHARMACEUTICAL CO. | S.P.A.R STERILE AMBULATORY RESERVOIR | 04/04/1999 |
| K230718 | Gilero, LLC | UTC 3mL Medication Cartridge | 06/15/2023 |
| K970678 | HARVARD APPARATUS, INC. | THE HARVARD LIBRARY | 01/09/1998 |
| K051079 | HOSPICARE, INC. | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY | 05/19/2005 |
| K160492 | Hospira, Inc | Hospira Sapphire Sets | 12/06/2016 |
| K171346 | ICU Medical | Sapphire Sets | 08/25/2017 |
| K961486 | IVAC MEDICAL SYSTEMS | IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT | 04/17/1998 |
| K142374 | ivWatch, LLC | ivWatch Model 400 | 02/13/2015 |
| K132618 | LIFESCAN, INC. | ONETOUCH REVEAL | 12/16/2013 |
| K070438 | MEDTRONIC MINIMED, INC. | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | 10/17/2007 |
| K021974 | MINIMED, INC. | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 | 08/06/2002 |
| K012262 | NATIONAL CUSTOM ENT., INC. | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | 09/12/2001 |
| K012259 | NATIONAL CUSTOM ENT., INC. | MEDFUSION 2001 & 2010, MODEL N7215IWC | 09/12/2001 |
| K012266 | NATIONAL CUSTOM ENT., INC. | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | 09/12/2001 |
| K030936 | RITA MEDICAL SYSTEMS INC | RITA CLIPS FOR INFUSION PUMPS | 04/01/2003 |
| K080227 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | 05/15/2008 |
| K082783 | SMITHS MEDICAL MD, INC. | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE | 12/17/2008 |
| K072955 | SMITHS MEDICAL MD, INC. | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) | 02/13/2008 |
| K091181 | SMITHS MEDICAL MD, INC. | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | 06/12/2009 |
| K071418 | SOOIL DEVELOPMENT CO., LTD. | DANA 3CC SYRINGE INSULIN RESERVOIR | 09/04/2007 |
| K193654 | WellDoc, Inc | BlueStar Rx | 04/07/2020 |
| K162225 | WellDoc, Inc | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | 11/22/2016 |
| K162532 | WELLDOC, INC | WellDoc BlueStar, WellDoc BlueStar Rx | 01/12/2017 |
| K112370 | WELLDOC, INC | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | 10/14/2011 |
| K120314 | WELLDOC, INC | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM | 02/24/2012 |
| K141273 | WELLDOC, INC | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | 07/08/2014 |
| K190013 | WellDoc, Inc. | WellDoc BlueStar | 11/04/2019 |
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