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510(k) Data Aggregation
K Number
K210714Device Name
Extended Reservoir
Manufacturer
Medtronic MiniMed, Inc.
Date Cleared
2022-04-06
(392 days)
Product Code
LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Medtronic MiniMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
Device Description
Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container designed for single use. The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
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K Number
K151236Device Name
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
Manufacturer
MEDTRONIC MINIMED, INC.
Date Cleared
2015-05-19
(8 days)
Product Code
PJT, PKU
Regulation Number
862.1350Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC MINIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring.
MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter.
The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.
Device Description
MiniMed® Connect is a secondary display of continuous glucose monitor and/or insulin pump data on a suitable consumer electronic device for insulin pump patients and their care partners. This system is designed as an optional accessory to compatible sensor-augmented pump systems.
MiniMed® Connect consists of a MiniMed® Connect app (for a local secondary display), the CareLink® Connect module of CareLink® Personal (for a remote secondary display), and the MiniMed® Connect uploader (for data transmission to the local app).
The MiniMed® Connect uploader is a small, battery-powered, ambulatory device that is carried with the patient in near proximity to the insulin pump. Its rechargeable battery is charged as needed (approximately once a day) using a USB Charger that accompanies the device.
The MiniMed® Connect uploader receives continuous glucose monitor and/or insulin pump data from the sensor-augmented insulin pump using a proprietary 916.5 MHz RF, and then converts it into a 2.4 GHz Bluetooth Low Energy (BLE) format. This BLE formatted data can then be read by the MiniMed® Connect app installed on a compatible consumer electronics device with BLE capabilities.
The MiniMed® Connect app reads the BLE data transmission and displays it on the patient's compatible consumer electronic device. The MiniMed® Connect app then uploads the continuous glucose monitor and/or insulin pump data to CareLink® Connect, the remote monitoring module of CareLink® Personal. Authorized care partners can access CareLink® Connect to view the patient's continuous glucose monitor and/or insulin pump data through an Internet-enabled consumer electronic device for the purpose of passive monitoring.
Accessories associated with this system include:
- USB Charger (for charging the MiniMed® Connect uploader) .
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K Number
K070438Device Name
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
Manufacturer
MEDTRONIC MINIMED, INC.
Date Cleared
2007-10-17
(244 days)
Product Code
MRZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC MINIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic CareLink™ USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes ther apy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.
Device Description
The Medtronic MiniMed CareLink USB Connector is an accessory device that facilitates wireless communication between compatible Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The hardware component of the CareLink USB Connector consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one USB connector that is compatible with a type A (female) USB port of a personal computer (PC) or a USB hub. The CareLink USB Connector has a form factor similar to a USB flash memory stick and will by recognized by the PC as a USB device. The CareLink USB Connector is designed for use with Medtronic MiniMed devices that use Paradigm radiofrequency telemetry. Data is transferred between Medtronic MiniMed Paradigm RF compatible devices and a personal computer (PC) using select Medtronic MiniMed data management software applications.
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