Advocate Redi-Code TD-4223

Device Name:

Redi-Code

Device Model:

TD-4223

Manufacturer:

Distributer: Pharma Supply Inc. (Advocate), 3381 Fairlane Farms Rd., Wellington, FL 33414, UNITED STATES.

OBL: Diabetic Supply of Suncoast Inc., Plaza Nuñez 3, PR-2, Vega Alta 00692, PUERTO RICO.

Regulatory: Diabetic Supply of Suncoast Inc., ℅ Matt Hedlund, 3924 NE 157th Place, Lake Forest Park, Washington 98155, UNITED STATES.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Limbs (Upper Arm, Forearm, Thigh & Calf)

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Advocate Redi-Code TD-4223 is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Measurements are taken from the upper arm, forearm, thigh and calf. It is intended for self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Advocate Redi-Code TD-4223 to measure blood glucose.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has not been clinically validated.