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MRZ — Accessories, Pump, Infusion Class II

FDA Device Classification

Classification Details

Product Code
MRZ
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230718gileroUTC 3mL Medication CartridgeJune 15, 2023
K220695elite biomedical solutionsElite Biomedical Solutions Dose Request CordApril 29, 2022
K201634chengdu shifeng medical technology coRG 3ml Medication CartridgeMarch 26, 2021
K193654welldocBlueStar RxApril 7, 2020
K191910b. braun melsugenSpaceStation MRIMarch 12, 2020
K190013welldocWellDoc BlueStarNovember 4, 2019
K173531b.braun medicalLockbox for Perfusor Space PCA Infusion PumpAugust 2, 2018
K171346icu medicalSapphire SetsAugust 25, 2017
K162532welldocWellDoc BlueStar, WellDoc BlueStar RxJanuary 12, 2017
K160492hospiraHospira Sapphire SetsDecember 6, 2016
K162225welldocWellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemNovember 22, 2016
K142374ivwatchivWatch Model 400February 13, 2015
K142333american i.v. products, inc. dba aivSMART LABEL, PROPOFOLDecember 18, 2014
K141273welldocWELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEJuly 8, 2014
K132618lifescanONETOUCH REVEALDecember 16, 2013
K120209american i.v. productsPATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLEApril 12, 2012
K120314welldocWELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMFebruary 24, 2012
K112370welldocWELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMOctober 14, 2011
K101806aideraAIDERA DIASEND SYSTEMDecember 7, 2010
K100066welldocDIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1July 15, 2010