||insulin vial protector/holder|
||Daily activity assist device.|
||The device is intended to protect an insulin vial or vials.
||The device is made of a variety of durable plastics and fabrics. All devices consist of an inner core that surrounds the vial for protection.
||The device functions independently providing a protective barrier to shield and protect the insulin vial.
||The device is intended to protect the insulin vial. The device itself does not act on the body at all.
|Regulation Medical Specialty
|| Physical Medicine
Office of Device Evaluation
Division of Neurological and Physical Medicine Devices
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.|
|If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
|Third Party Review
||Not Third Party Eligible