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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high level disinfection reprocessing instrument for ultrasonic transducers, mist
Definition To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeOUJ
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOSONICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2 2
Device Displays Incorrect Message 1 1
Chemical Problem 1 1
Chemical Spillage 1 1
Contamination /Decontamination Problem 1 1
Output Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 1 1
Chemical Exposure 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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