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PYVClass II

Hospital Continuous Glucose Monitoring System

21 CFR 862.1345 / Clinical Chemistry
FDA source (opens on fda.gov)

PYV is the FDA product code for Hospital Continuous Glucose Monitoring System, a class II device type, regulated under 21 CFR 862.1345. FDA's definition for this code reads: "Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PYV
Device name
Hospital Continuous Glucose Monitoring System
FDA definition
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
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

No registered establishment in MDM’s records lists product code PYV.