Omnipod (Dash) View APP

Basic Information

• Brand Name: Omnipod (Dash) View APP
• Primary DI: 10385081120272
• Version / Model: 1.3.1
• Catalog Number: 18239
• Company Name: INSULET CORPORATION
• Labeler DUNS: 051334402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-20
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: c01097de-8e43-422c-b74c-f6a766ae0236

Device Description

Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Manufacturing Date: No
• 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
PKU	Insulin Pump Secondary Display	Clinical Chemistry	862.1350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64656	Ambulatory insulin infusion pump software, data-display	A software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10385081120272	GS1

Customer Contacts

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