Omnipod 5 Controller APP

GUDID 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP

INSULET CORPORATION

Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 10385081120302
• NIH Device Record Key: dc84f06e-2555-4835-a29f-bdf9c0d6589b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod 5 Controller APP
• Version Model Number: 1.0
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com
• Phone: 978-600-7155
• Email: RA@insulet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385081120302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203768

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

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: 2022-03-07
• Device Publish Date: 2022-02-25

Devices Manufactured by INSULET CORPORATION

• 20385084000103 - Omnipod Go Insulin Delivery Device 10U/day POD: 2023-08-28 Omnipod Go Insulin Delivery Device 10U/day POD
• 20385084000158 - Omnipod Go Insulin Delivery Device 15U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 15U/day
• 20385084000202 - Omnipod Go Insulin Delivery Device 20U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 20U/day
• 20385084000257 - Omnipod Go Insulin Delivery Device 25U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 25U/day
• 20385084000301 - Omnipod Go Insulin Delivery Device 30U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 30U/day
• 20385084000356 - Omnipod Go Insulin Delivery Device 35U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 35U/day
• 20385084000400 - Omnipod Go Insulin Delivery Device 40U/day: 2023-08-28 Omnipod Go Insulin Delivery Device 40U/day
• 10385081120302 - Omnipod 5 Controller APP: 2022-03-07Actual downloadable APP, called Omnipod 5 Controller APP
• 10385081120302 - Omnipod 5 Controller APP: 2022-03-07 Actual downloadable APP, called Omnipod 5 Controller APP