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PKUClass II

Insulin Pump Secondary Display

21 CFR 862.1350 / Clinical Chemistry
FDA source (opens on fda.gov)

PKU is the FDA product code for Insulin Pump Secondary Display, a class II device type, regulated under 21 CFR 862.1350. FDA's definition for this code reads: "The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PKU
Device name
Insulin Pump Secondary Display
FDA definition
The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Regulation
21 CFR 862.1350
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code