Omnipod (Dash) Display App. 18239

GUDID 10385081120265

Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252

INSULET CORPORATION

Ambulatory insulin infusion pump software, data-display

• Primary Device ID: 10385081120265
• NIH Device Record Key: 2f4cb276-8c75-4958-880a-83cc0bcd4460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod (Dash) Display App.
• Version Model Number: 1.3.1
• Catalog Number: 18239
• 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: 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
• 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
• 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
• 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	10385081120265 [Primary]

FDA Product Code

• PKU: Insulin Pump Secondary Display

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: 2021-03-01
• Device Publish Date: 2021-02-20

Devices Manufactured by INSULET CORPORATION

• 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
• 10385083000503 - Omnipod 5 Starter Kit: 2024-07-29 Omnipod 5 Starter Kit mg/dl
• 10385083000565 - Omnipod 5 Controller APP: 2024-07-29 Omnipod 5 Controller APP
• 20385083000531 - Omnipod 5 Pod: 2024-05-13 Omnipod 5 Pod
• 20385084000103 - Omnipod Go Insulin Delivery Device 10U/day POD: 2023-08-28 Omnipod Go Insulin Delivery Device 10U/day POD