Omnipod 5 Controller APP

GUDID 10385083000336

Omnipod 5 Controller APP

Insulet Corporation

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 10385083000336
• NIH Device Record Key: b607ec5f-3be5-4f59-8fdc-432b95148344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod 5 Controller APP
• Version Model Number: M009-S-AP
• Company DUNS: 051334402
• Company Name: Insulet Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com
• Phone: 1800-591-3455
• Email: RegulatoryAffairs@insulet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385083000336 [Primary]

FDA Product Code

• QRX: Continuous Glucose Monitor Informed Insulin Dose Calculator

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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Omnipod 5 Controller APP]

• 10385081120302: Actual downloadable APP, called Omnipod 5 Controller APP
• 10385083000565: Omnipod 5 Controller APP
• 10385083000336: Omnipod 5 Controller APP