Product Code: OZO


Products Classified as OZO

713Automated Insulin Dosing , Threshold Suspend

Total Product Life Cycle (TPLC) Devices

713Automated Insulin Dosing , Threshold Suspend

FDA Consensus Standards

Automated Insulin Dosing , Threshold Suspend [35909]21 CFR Unclassified 🔎
Automated Insulin Dosing , Threshold Suspend [35812]21 CFR Unclassified 🔎
Automated Insulin Dosing , Threshold Suspend [33613]21 CFR Unclassified 🔎
Automated Insulin Dosing , Threshold Suspend [35910]21 CFR Unclassified 🔎

Pre-market Approvals for OZO

P180008t:slim X2 Insulin Pump with Basal-IQ TechnologyTandem Diabetes Care, Inc.
P150001MiniMed 630G SystemMEDTRONIC MINIMED
P120010MiniMed 530G SystemMEDTRONIC Inc.

Global Unique Device Identification Database

40301937283350Artificial Pancreas Device System, Threshold Suspend
0193-6262-01Artificial Pancreas Device System, Threshold Suspend
00301936260019Artificial Pancreas Device System, Threshold Suspend
00613994933072Artificial pancreas device system, threshold suspend
00643169933224Artificial pancreas device system, threshold suspend
00643169933217Artificial pancreas device system, threshold suspend
00643169933200Artificial pancreas device system, threshold suspend
00643169933194Artificial pancreas device system, threshold suspend
00643169933187Artificial pancreas device system, threshold suspend
00643169933033Artificial pancreas device system, threshold suspend
00643169933026Artificial pancreas device system, threshold suspend
00643169933019Artificial pancreas device system, threshold suspend
00643169933002Artificial pancreas device system, threshold suspend
00643169932999Artificial pancreas device system, threshold suspend
00643169878648Artificial pancreas device system, threshold suspend

Maude Adverse Events

530G INSULIN PUMP MMT-751NASMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-551NALMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751NABMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751LNASMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715KL 630GMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
PUMP MMT-1714K 630G BLACK MMOL CANADAMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751LNASMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751LNASMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-551NALMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
SENSOR ENLITE MMT-7008AMEDTRONIC MINIMED2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751NALMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
630G INSULIN PUMP MMT-1715KL 630GMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
530G INSULIN PUMP MMT-751LNASMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
630G INSULIN PUMP MMT-1715K 630G BLACK MGMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2, BASAL-IQ, MMOL/LTANDEM DIABETES CARE2020-03-31
PUMP MMT-1715KM 630G 3ML BLACK MEDI ?MEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGYTANDEM DIABETES CARE2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.