Product Code: FPA


Products Classified as FPA

2579Set, Administration, IntravascularIntravascular Administration Set.

Total Product Life Cycle (TPLC) Devices

2579Set, Administration, IntravascularIntravascular Administration Set.

FDA Consensus Standards

Set, Administration, Intravascular [31768]21 CFR §880.5440 🔎
Set, Administration, Intravascular [31780]21 CFR §880.5440 🔎
Set, Administration, Intravascular [33622]21 CFR §880.5440 🔎
Set, Administration, Intravascular [30510]21 CFR §880.5440 🔎
Set, Administration, Intravascular [33624]21 CFR §880.5440 🔎
Set, Administration, Intravascular [33623]21 CFR §880.5440 🔎
Set, Administration, Intravascular [34074]21 CFR §880.5440 🔎

Pre-market Notifications for FPA

K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.
K210544Medtronic Extended Infusion SetUnomedical A/S
K210430Intravascular Extension SetBaxter Healthcare Corporation
K210381I.V. Administration SetBQ PLUS Medical Co., Ltd.
K203796Firefly Needleless ConnectorPuraCath Medical, Inc
K203609Intravascular Administration SetsBaxter Healthcare Corporation
K202672Precision Delivery Infusion SetQuest Medical, Inc.
K202618IV Administration SetsB. Braun Medical Inc.
K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC
K201626Safety Subcutaneous Infusion SetEpic Medical Pte. Ltd.
K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies Inc.
K200425Female Luer Lock CapMedSafety Solutions LLC
K193088MaxZero Extension Sets With Needle-Free Connector(s)Carefusion, Inc.
K192647Neria Guard Infusion SetUnomedical A/s
K192375Intellifuse Administration And Intellifuse Blood Administration SetsSmiths Medical ASD, Inc.

Global Unique Device Identification Database

20386120008909Set, Administration, Intravascular
20386120008893Set, Administration, Intravascular
20386120008886Set, Administration, Intravascular
20386120008879Set, Administration, Intravascular
20386120008862Set, Administration, Intravascular
20386120008855Set, Administration, Intravascular
20386120008848Set, Administration, Intravascular
20386120008831Set, Administration, Intravascular
20386120008824Set, Administration, Intravascular
20386120008817Set, Administration, Intravascular
20386120008800Set, Administration, Intravascular
20386120008794Set, Administration, Intravascular
20386120008787Set, Administration, Intravascular
20386120008770Set, Administration, Intravascular
20386120008763Set, Administration, Intravascular

Maude Adverse Events

CADD 100 ML MEDICATION CASSETTE RESERVOIRSMITHS MEDICAL ASD, INC.2020-03-31
SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPESMITHS MEDICAL ASD, INC.2020-03-31
CADD 100 ML MEDICATION CASSETTE RESERVOIRSMITHS MEDICAL ASD, INC.2020-03-31
CADD 100 ML MEDICATION CASSETTE RESERVOIRSMITHS MEDICAL ASD, INC.2020-03-31
SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPESMITHS MEDICAL ASD, INC.2020-03-31
SET, ADMIN, CADD, 108", SPIKESMITHS MEDICAL ASD, INC.2020-03-31
SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPESMITHS MEDICAL ASD, INC.2020-03-31
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SETBAXTER HEALTHCARE CORPORATION2020-03-31
MICRO-VOLUME RADIATION STERILIZED EXTENSION SETSBAXTER HEALTHCARE CORPORATION2020-03-31
SMITHS MEDICAL CADD CLEO INFUSION SETSMITHS MEDICAL ASD, INC.2020-03-31
DUO-VENT CLEARLINK LUER ACTIVATED VALVEBAXTER HEALTHCARE CORPORATION2020-03-31
DUO-VENT CLEARLINK LUER ACTIVATED VALVEBAXTER HEALTHCARE CORPORATION2020-03-31
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SETBAXTER HEALTHCARE CORPORATION2020-03-31
CONTINU-FLO SOLUTION SET DUO-VENT SPIKE, 3 LUER ACTIVATED VALVES, MALE LUERBAXTER HEALTHCARE CORPORATION2020-03-31
ONE-LINK NEUTRAL LUER ACTIVATED DEVICEBAXTER HEALTHCARE CORPORATION2020-03-31
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTORBAXTER HEALTHCARE CORPORATION2020-03-31
SURE-T? PARADIGM?2020-03-31
QUICK-SET? PARADIGM?2020-03-31
CADD CASSETTE 100 ML W/ FLOWSTOPSMITHS MEDICAL ASD, INC.2020-03-30
CLEARLINK CONTINU-FLO SOLUTION SETBAXTER HEALTHCARE CORPORTION2020-03-30
DUO-VENT CLEARLINK LUER ACTIVATED VALVEBAXTER HEALTHCARE CORPORATION2020-03-30
CADD ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2020-03-30
NISET, ADMINISTRATION, INTRAVASCULARBAXTER HEALTHCARE CORPORATION2020-03-30
CADD ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2020-03-30
CADD ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2020-03-30
ONCOLOGY KIT W/SPINNING SPIROS? W/RED CAP; C-CLIP; PRIMING CAPICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.2020-03-30
CLEARLINK SOLUTION SETBAXTER HEALTHCARE CORPORATION2020-03-30
ACCU-CHEK ? RAPIDLINK INFUSION SETROCHE DIABETES CARE, INC.2020-03-30
NDEHP PLUMSET 2CLAVES-SLICU MEDICAL COSTA RICA LTD.2020-03-30
DUO-VENT CLEARLINK LUER ACTIVATED VALVEBAXTER HEALTHCARE CORPORATION2020-03-30
16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIROICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.2020-03-30
NISET, ADMINISTRATION, INTRAVASCULARBAXTER HEALTHCARE CORPORATION2020-03-30
16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIROICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.2020-03-30
16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIROICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.2020-03-30
16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIROICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.2020-03-30
CLEARLINK/DUO-VENTBAXTER HEALTHCARE CORPORATON2020-03-30
CLEARLINK/DUO-VENTBAXTER HEALTHCARE CORPORATION2020-03-30
CLEARLINK NON-DEHP SOLUTION SETBAXTER HEALTHCARE CORPORATION2020-03-30
CLEARLINK/CONTINU-FLO SOLUTION SET 109", 3 LUER VALVES MALE LUERBAXTER HEALTHCARE CORPORATION2020-03-30
CADD ADMINISTRATION SET- NON FLOW STOPSMITHS MEDICAL ASD, INC2020-03-29
SMITHS MEDICAL CADD ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2020-03-28
ACCU-CHEK ? INSIGHT FLEXROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? INSIGHT FLEXROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? INSIGHT FLEXROCHE DIABETES CARE, INC.2020-03-28
ALARIS? PUMP MODULE ADMINISTRATION SETCAREFUSION2020-03-28
ALARIS? PUMP MODULE ADMINISTRATION SETCAREFUSION2020-03-28
ALARIS PCA MODULE SETCAREFUSION2020-03-28
CADD CLEO INFUSION SETSSMITHS MEDICAL ASD,INC.2020-03-27
ALARIS PUMP MODULE ADMINISTRATION SETCAREFUSION2020-03-27
DUO-VENT CLEARLINK LUER ACTIVATED VALVEBAXTER HEALTHCARE CORPORATION2020-03-27

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