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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device supplies, blood-bank
Regulation Description Blood bank supplies.
Product CodeKSS
Regulation Number 864.9050
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  BK900022  Blood Bank Supplies
HARVEST
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 8
MICRO TYPING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Particulates 1
Improper or incorrect procedure or method 1
No Information 1
Total Device Problems 3

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