Product Code: LZG


Products Classified as LZG

2669Pump, Infusion, InsulinInfusion Pump.

Total Product Life Cycle (TPLC) Devices

2669Pump, Infusion, InsulinInfusion Pump.

FDA Consensus Standards

Pump, Infusion, Insulin [31768]21 CFR §880.5725 🔎
Pump, Infusion, Insulin [33613]21 CFR §880.5725 🔎
Pump, Infusion, Insulin [35910]21 CFR §880.5725 🔎

Pre-market Notifications for LZG

K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation
K180045Omnipod DASH Insulin Management SystemInsulet Corporation
K162296OmniPod Insulin Management SystemINSULET CORPORATION
K162080T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.
K160482T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.
K160252OmniPod Insulin Management SystemINSULET CORPORATION
K160056T:slim Insulin Delivery SystemTandem Diabetes Care, Inc.
K143189T:flex Insulin Delivery SystemTandem Diabetes Care, Inc.
K142619Snap Insulin Pump SystemASANTE SOLUTIONS, INC
K141758T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE, INC.
K140439OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION
K133593T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE, INC.
K131294OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION
K122953OMNIPOD INSULIN MANAGMENT SYSTEMINSULET CORPORATION

Global Unique Device Identification Database

10385609600033Pump, Infusion, Insulin
10385609600026Pump, Infusion, Insulin
10385609600019Pump, Infusion, Insulin
40385609400030Pump, Infusion, Insulin
00385609400025Pump, Infusion, Insulin
40385609400016Pump, Infusion, Insulin
00365702647107Pump, Infusion, Insulin
20353885011673PUMP, INFUSION, INSULIN
20353885010201PUMP, INFUSION, INSULIN
00853052007516Pump, Infusion, Insulin
00853052007509Pump, Infusion, Insulin
00853052007493Pump, Infusion, Insulin
00853052007479Pump, Infusion, Insulin
00853052007240Pump, Infusion, Insulin
00852162004798Pump, Infusion, Insulin

Maude Adverse Events

MMT-712 PARADIGM INSULIN PUMPMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
MMT-715 PARADIGM INSULIN PUMPMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
MMT-715 PARADIGM INSULIN PUMPMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:FLEX INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
TANDEM T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
ACCU-CHEK ? SPIRIT COMBOROCHE DIABETES CARE, INC.2020-03-31
T:FLEX INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
MMT-715 PARADIGM INSULIN PUMPMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
TANDEM T:SLIM INSULIN DELIVERY SYSTEMTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
MMT-715 PARADIGM INSULIN PUMPMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
T:SLIM X2 INSULIN PUMPTANDEM DIABETES CARE2020-03-31
OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31
OMNIPOD INSULIN MANAGEMENT SYSTEMINSULET CORPORATION2020-03-31
OMNIPOD INSULIN PUMPINSULET CORPORATION2020-03-31

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