RSVR MMT-326A 10PK PDGM 1.8ML 21L 3YR


Product Overview

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 Identifiers

Device 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


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