FDA Product Code OZP

Product Code: OZP

Products Classified as OZP

Automated Insulin Dosing Device System, Single Hormonal Control

Total Product Life Cycle (TPLC) Devices

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Consensus Standards

Automated Insulin Dosing Device System, Single Hormonal Control [35909]	21 CFR Unclassified 🔎
Automated Insulin Dosing Device System, Single Hormonal Control [35812]	21 CFR Unclassified 🔎
Automated Insulin Dosing Device System, Single Hormonal Control [33613]	21 CFR Unclassified 🔎
Automated Insulin Dosing Device System, Single Hormonal Control [35910]	21 CFR Unclassified 🔎

Pre-market Approvals for OZP

P160017

MiniMed 670G System

MEDTRONIC MINIMED, INC.

Global Unique Device Identification Database

00643169980525	Artificial pancreas device system, single hormonal control
00643169955691	Artificial pancreas device system, single hormonal control
00643169955684	Artificial pancreas device system, single hormonal control
00643169946057	Artificial pancreas device system, single hormonal control
00643169946040	Artificial pancreas device system, single hormonal control
00643169939219	Artificial pancreas device system, single hormonal control
00643169939202	Artificial pancreas device system, single hormonal control
40643169771435	Automated insulin dosing device system, single hormonal control
00643169704060	Artificial pancreas device system, single hormonal control
00763000215545	Automated insulin dosing device system, single hormonal control
00763000215538	Automated insulin dosing device system, single hormonal control
00763000166564	Automated insulin dosing device system, single hormonal control
00763000166540	Automated insulin dosing device system, single hormonal control
00763000166526	Automated insulin dosing device system, single hormonal control
00763000157043	Automated insulin dosing device system, single hormonal control

Maude Adverse Events

PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1781K 670G V4.11 MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1782K 670G V4.11 MM	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
KIT MMT-1762WWK 670G V4.11 SF MM	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
KIT MMT-1760KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1782K 670G V4.11 MM	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
SENSOR MMT-7020C1 GS3 5PK 9L OUS1	MEDTRONIC MINIMED	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1781K 670G V4.11 MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
670G INSULIN PUMP MMT-1780KL	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
SENSOR MMT-7020A ENLITE3 5PK US	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1780KPK 670G PATHWAY BLACK MG	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31
PUMP MMT-1782K 670G V4.11 MM	MEDTRONIC PUERTO RICO OPERATIONS CO.	2020-03-31