Patient Personal Hygiene Kit

Device Code: 2521

Product Code(s): NSB

Definition: This Device Contains Items Given To An Individual During Their Hospital Stay.

Device Classification Information

Device Type ID2521
Device NamePatient Personal Hygiene Kit
Regulation DescriptionManual Toothbrush.
Regulation Medical SpecialtyDental
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number872.6855 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNSB
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2521
DevicePatient Personal Hygiene Kit
Product CodeNSB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Toothbrush.
CFR Regulation Number872.6855 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:13:43

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