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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calculator, drug dose
Regulation Description Predictive pulmonary-function value calculator.
Product CodeNDC
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
COLLABORATIVEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIMENSIONAL DOSING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DECISIONS NETWORK
  SUBSTANTIALLY EQUIVALENT 1
PRONIA MEDICAL SYSTEM, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Inaccurate delivery 9
Incorrect software programming calculations 8
Use of Device Issue 8
Device alarm system issue 6
Other (for use when an appropriate device code cannot be identified) 4
Inappropriate prompts 3
Not audible alarm 2
Computer software issue 2
Installation-related problem 2
No Known Device Problem 2
Patient Data Issue 2
Application program issue 1
Total Device Problems 49

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