Omnipod Go Insulin Delivery Device 35U/day

Omnipod Go Insulin Delivery Device 35U/day
Omnipod Go Insulin Delivery Device 35U/day - POD-INS-I1-3525

A badge-like, battery-powered, disposable device designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive) to provide basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. The device integrates an electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle; it is patient operated with the use of integral controls or a remote control unit (not included). This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LZG

Device Name: Pump, Infusion, Insulin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

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 Id: 20385084000356

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10385084000359

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: 5 Pack Box

Device Id: 10385084000359

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