Omnipod 5 Starter Kit

GUDID 10385083000503

Omnipod 5 Starter Kit mg/dl

Insulet Corporation

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 10385083000503
• NIH Device Record Key: c7d9301b-0cae-4198-bd5e-84e4c7309660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod 5 Starter Kit
• Version Model Number: SKT-M001-G-X9
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@XXX.com
• Phone: 1800-591-3455
• Email: XXX@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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 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 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385083000503 [Primary]

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-02-22

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