Omnipod PodPals

GUDID 10385081120234

Ambulatory insulin infusion pump/blood glucose analyser system

Primary Device ID	10385081120234
NIH Device Record Key	61723978-b4b6-4b35-a50c-948c8e70b9fd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omnipod PodPals
Version Model Number	POD-X9-990
Company DUNS	051334402
Company Name	INSULET CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
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	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	10385081120234 [Primary]
GS1	20385081120231 [Package] Package: Box Adhesive Pads [10 Units] In Commercial Distribution
GS1	20385083000104 [Package] Package: Box Adhesive Pads [3 Units] In Commercial Distribution

KGX	Tape And Bandage, Adhesive

Steralize Prior To Use	false
Device Is Sterile	true

10385081120234	Omnipod Adhesive Overlay (Podpals)
20385081120330	Omnipod Adhesive Overlay (PodPals) non-sterile