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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, urea (breath or blood)
Product CodeMSQ
Regulation Number 866.3110
Device Class 1


Premarket Reviews
ManufacturerDecision
EXALENZ BIOSCIENCE LTD.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K130524  BREATHID HP SYSTEM
  2.  K162150  BreathID Hp Lab System
  3.  K173772  BreathID Hp System
  4.  K173777  BreathID Hp Lab System
  5.  K193610  BreathID Smart System
HEMA METRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 3
OTSUKA PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 4 4
2016 2 2
2017 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Reaction 3 3
Hyperglycemia 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Miscarriage 1 1
Nausea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Swelling 1 1
Tachycardia 1 1
Vomiting 1 1
Burning Sensation 1 1
Tingling 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exalenz Bioscience Ltd II Oct-12-2011
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