Omnipod 5 Pod

GUDID 10385083000213

Omnipod 5 Pod

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: 10385083000213
• NIH Device Record Key: 83f9e052-d144-4469-8ea5-c1bc6b9937e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod 5 Pod
• Version Model Number: POD-BLE-H1-520
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com
• Phone: 1-800-591-3455
• Email: xxxx@xxx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385083000114 [Primary]
GS1	10385083000138 [Package]; Contains: 10385083000114; Package: 10 Pack Box [10 Units]; In Commercial Distribution
GS1	10385083000213 [Package]; Contains: 10385083000114; Package: 5 Pack Box [5 Units]; In Commercial Distribution

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: true

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: 2022-03-07 Actual downloadable APP, called Omnipod 5 Controller APP