KIT MMT
MiniMed ® Connect - MMT-7000NAU
Device Description
A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller.
Environmental Conditions
- 95.00
- 0.00
- 55.00
- -20.00
- 131.00
- -4.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PKU
Device Name: Insulin Pump Secondary Display
Device Class: 2
Physical State: Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.
Definition: The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Receives and displays real-time patient data from an insulin pump.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: n/a
Regulation Number: 862.1350
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00643169873827
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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