Omnipod PodPals

Basic Information

• Brand Name: Omnipod PodPals
• Primary DI: 10385081120333
• Version / Model: POD-X9-990NS
• Company Name: Insulet Corporation
• Labeler DUNS: 051334402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-16
• Public Version: 2
• Public Version Date: 2025-12-04
• Public Version Status: Update
• Public Device Record Key: 64b4c3e1-5cf1-40b5-af15-1a644e73cdd0

Device Description

Omnipod Adhesive Overlay (PodPals) non-sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20385081120330	GS1	10-Pack Box	10	In Commercial Distribution
Primary	10385081120333	GS1
Package	20385081120347	GS1	3-Pack Box	3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]