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Animas Vibe Insulin Pump and Continuous Glucose Monitoring System approved by FDA for use in children

Press releases may be edited for formatting or style | January 11, 2016

Contraindications: Insulin pump therapy is not recommended for people unwilling or unable to test their blood glucose four to six times per day, unwilling or unable to see their healthcare professional regularly, or whose vision or hearing does not allow recognition of pump alerts, warnings, and alarms. The Animas® Vibe® Insulin Pump must be removed before MRI or CT scan, and the Dexcom G4® PLATINUM Sensor and Transmitter must be removed before MRI, CT scan, or diathermy treatment. Taking acetaminophen-containing medications while wearing the sensor may falsely raise sensor glucose readings.

Warnings: Connecting to the pump before receiving the necessary training could result in serious injury or death. Younger children may inadvertently press the pump buttons and deliver insulin, which can lead to hypoglycemic events. Caregivers are responsible for helping to ensure safe and effective delivery of insulin to people in their care, including using the safety features on the Animas® Vibe® System to help prevent injury. CGM glucose readings are not to be used to make treatment decisions. The sensor and transmitter do not replace a blood glucose meter. The sensor and transmitter are not to be used during pregnancy or while on dialysis. Sensor placement is only approved for sites under the skin of the belly (abdomen) in adults and the belly or upper buttocks for ages 2 to 17 (pediatrics). Patients should seek professional medical help if a sensor breaks and no portion of it is visible above the skin, or if there is infection or inflammation. Any broken sensors or adverse events should be reported to Customer Service. Contact Customer Service at 1-877-937-7867 or visit www.animas.com/safety for detailed indications for use and safety information.

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About Animas
With a shared vision of "creating a world without limits" for people with diabetes, Animas Corporation is a part of the Johnson & Johnson Diabetes Care Companies (JJDCC), a cross-company collaboration that reflects an ongoing commitment to better serve the diabetes community with integrated solutions that meet the needs of people with diabetes across the continuum of care. JJDCC includes LifeScan, Inc., a world leader in blood glucose monitoring; Calibra Medical, Inc. developer of a unique 3-day wearable insulin patch, and Animas Corporation, which provides a wide range of insulin delivery products for people living with diabetes, including the Animas® Vibe® insulin pump and CGM system and the OneTouch® Ping® Glucose Management System. Animas, from the Latin word meaning "true inner self or soul," has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit www.animas.com.

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