Omnipod 5 Pod

GUDID 20385083000425

Ambulatory insulin infusion pump/interstitial glucose monitoring system

Primary Device ID	20385083000425
NIH Device Record Key	60548b36-10f9-47ac-87c0-2a11704d6daf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omnipod 5 Pod
Version Model Number	POD-OMNI-I1-6220
Company DUNS	051334402
Company Name	Insulet Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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	10385083000411 [Primary]
GS1	20385083000425 [Package] Contains: 10385083000411 Package: 5-Pack [10 Units] In Commercial Distribution

QFG	Alternate Controller Enabled Insulin Infusion Pump

Steralize Prior To Use	false
Device Is Sterile	true