Product code PDT

Device name

Burn Resuscitation Decision Support Software

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.1890

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.

Source

FDA openFDA device classification dataset