RSVR MMT
MiniMed Reservoir - MMT-326A
Device Description
An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OZP
Device Name: Automated Insulin Dosing Device System, Single Hormonal Control
Device Class: 3
Physical State: May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software
Definition: An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Submission Type ID: 2
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses a glucose monitoring system to measure glucose levels and increases or reduces insulin infusion from an insulin pump
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Code: FRN
Device Name: Pump, Infusion
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5725
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 40643169771435
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00643169771437
Package Quantity: 72
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CT
Device Id: 00643169771437
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
Device Id: 70643169771436
Device Type: Unit of Use
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