Omnipod PodPals

GUDID 20385081120330

Omnipod Adhesive Overlay (PodPals) non-sterile

Insulet Corporation

Dressing-fixation skin adhesive tape, non-silicone
Primary Device ID20385081120330
NIH Device Record Key64b4c3e1-5cf1-40b5-af15-1a644e73cdd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnipod PodPals
Version Model NumberPOD-X9-990NS
Company DUNS051334402
Company NameInsulet Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com
Phone800-591-3455
EmailRA@insulet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110385081120333 [Primary]
GS120385081120330 [Package]
Contains: 10385081120333
Package: 10-Pack Box [10 Units]
In Commercial Distribution
GS120385081120347 [Package]
Contains: 10385081120333
Package: 3-Pack Box [3 Units]
In Commercial Distribution

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-04
Device Publish Date2025-04-16

On-Brand Devices [Omnipod PodPals]

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

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