Omnipod 5 Controller APP

GUDID 10385083000565

Ambulatory insulin infusion pump/interstitial glucose monitoring system

Primary Device ID	10385083000565
NIH Device Record Key	5903db01-3d96-42a2-b91c-a8311f2e5bdb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omnipod 5 Controller APP
Version Model Number	M009-3P-AP
Company DUNS	051334402
Company Name	Insulet Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10385083000565 [Primary]

QFG	Alternate Controller Enabled Insulin Infusion Pump

Steralize Prior To Use	false
Device Is Sterile	false

10385081120302	Actual downloadable APP, called Omnipod 5 Controller APP
10385083000565	Omnipod 5 Controller APP
10385083000336	Omnipod 5 Controller APP