Omnipod Discover

GUDID 10385083000152

Omnipod Data Management System

Insulet Corporation

Diabetes patient management software

• Primary Device ID: 10385083000152
• NIH Device Record Key: 108c6f54-ab9c-4c32-ba25-b3b9ae8d3960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod Discover
• Version Model Number: B010-D-DP
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com
• Phone: 1-800-591-3455
• Email: RA@insulet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385083000152 [Primary]

FDA Product Code

• PHV: Continuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by Insulet Corporation

• 10385083000152 - Omnipod Discover: 2025-12-12Omnipod Data Management System
• 10385083000152 - Omnipod Discover: 2025-12-12 Omnipod Data Management System
• 20385083000425 - Omnipod 5 Pod: 2025-12-12 Omnipod 5 Pod
• 10385083000459 - Omnipod 5 Controller APP: 2025-12-09 Omnipod 5 Controller APP iOS V2.x
• 20385081120330 - Omnipod PodPals: 2025-12-04 Omnipod Adhesive Overlay (PodPals) non-sterile
• 10385083000336 - Omnipod 5 Controller APP: 2024-07-30 Omnipod 5 Controller APP
• 20385081120019 - Omnipod: 2024-07-29 Eros PDM (Personal Diabetes Manager)
• 10385081140003 - Omnipod: 2024-07-29 Eros PDM(Personal Diabetes Manager)
• 20385082000020 - Omnipod DASH Pod: 2024-07-29 DASH Pod