Omnipod 14500-5A

GUDID 10385081140003

Eros PDM(Personal Diabetes Manager)

Insulet Corporation

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 10385081140003
• NIH Device Record Key: 49436ff9-b4d6-4b7e-96e4-df70deed240c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod
• Version Model Number: UST400
• Catalog Number: 14500-5A
• 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: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com
• Phone: 8005913455
• Email: xxxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385081140003 [Primary]
GS1	20385081140000 [Package]; 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: 4
• Public Version Date: 2024-07-29
• Device Publish Date: 2016-09-23

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)