Omnipod 18900-5A

GUDID 20385081120019

Eros PDM (Personal Diabetes Manager)

Insulet Corporation

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 20385081120019
• NIH Device Record Key: b792a22a-86cc-4767-ad74-2330a5785b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod
• Version Model Number: UST400
• Catalog Number: 18900-5A
• Company DUNS: 051334402
• Company Name: Insulet Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com
• Phone: 800-591-3455
• Email: xxxx@xxxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385081120012 [Primary]
GS1	20385081120019 [Package]; Contains: 10385081120012; Package: Starter Kit [1 Units]; In Commercial Distribution

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-07-29
• Device Publish Date: 2018-03-05

On-Brand Devices [Omnipod]

• 10385081120036: Eros Pod Insulin Pump.
• 10385081120005: Eros Pod Insulin pump.
• 10385081140003: Eros PDM(Personal Diabetes Manager)
• 20385081120019: Eros PDM (Personal Diabetes Manager)