Product Code: FRN


Products Classified as FRN

2602Pump, InfusionInfusion Pump.

Total Product Life Cycle (TPLC) Devices

2602Pump, InfusionInfusion Pump.

FDA Consensus Standards

Pump, Infusion [31768]21 CFR §880.5725 🔎
Pump, Infusion [29436]21 CFR §880.5725 🔎
Pump, Infusion [14823]21 CFR §880.5725 🔎
Pump, Infusion [34430]21 CFR §880.5725 🔎

Pre-market Notifications for FRN

K220417Spectrum IQ Infusion System With Dose IQ Safety SoftwareBaxter Healthcare Corporation
K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems
K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableFresenius Kabi AG
K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoFresenius Kabi AG
K200176FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc., Dba KORU Medical Systems
K192860Sapphire Infusion Pump, Sapphire Administration SetsQ Core Medical Ltd.
K190182Unity Subcutaneous Delivery System For RemodulinDEKA Research & Development
K183311Invenix Infusion System (IIS)Ivenix, Inc.
K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation
K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical Inc
K172653Power InfuserZOLL Medical Corporation
K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc., DBA RMS Medical Products
K161667Sapphire Infusion PumpQ Core Medical Ltd.
K161469Plum 360(TM) Infusion System With MedNet/ Smart Card Plug And Play ModuleHospira, Inc
K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC

Global Unique Device Identification Database

30610586100509Pump, infusion
30610586100486Pump, infusion
30610586100479Pump, infusion
30610586100462Pump, infusion
30610586100196Pump, infusion
30610586100189Pump, infusion
30610586100172Pump, infusion
00610586032595Pump, infusion
00610586032335Pump, infusion
00610586031901Pump, infusion
00610586026693Pump, infusion
00610586019145Pump, infusion
00610586017073Pump, infusion
00610586017004Pump, infusion
00610586016977Pump, infusion

Maude Adverse Events

SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION2020-03-31
SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION2020-03-31
SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION2020-03-31
MEDFUSION SYRINGE PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION SYRINGE PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD LEGACY 1 INFUSION SYSTEMSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION SYRINGE PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION SYRINGE PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD-MS3 AMBULATORY INFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD-MS3 AMBULATORY INFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD-MS3 AMBULATORY INFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
SPECTRUM INFUSION PUMPBAXTER HEALTHCARE CORPORATION2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD LEGACY 1 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD LEGACY 1 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD LEGACY 1 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD LEGACY 1 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
MEDFUSION PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD LEGACY 1 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
CADD MS3 GRAY SLATESMITHS MEDICAL ASD,INC2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SMITHS MEDICAL CADD SOLIS VIP PUMPSMITHS MEDICAL ASD, INC.2020-03-31
SMITHS MEDICAL MEDFUSION 3500 PUMPSSMITHS MEDICAL ASD, INC.2020-03-31
RESERVOIR 1.8ML MMT-326AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SMITHS MEDICAL CADD SOLIS VIP PUMPSMITHS MEDICAL ASD, INC.2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
RESERVOIR 3ML MMT-332AMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
CADD MS3 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD MS3 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
CADD MS3 PUMPSMITHS MEDICAL ASD, INC.2020-03-31
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