| Device |
insulin vial protector/holder |
| Regulation Description |
Daily activity assist device. |
| Definition |
The device is intended to protect an insulin vial or vials |
| Physical State |
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. |
| Technical Method |
The device functions independently providing a protective barrier to shield and protect the insulin vial. |
| Target Area |
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 |
| Review Panel |
General Hospital |
|---|
| Product Code | OJL |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
890.5050
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| 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. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
