• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device device, warming. blood and plasma
Regulation Description Blood and plasma warming device.
Product CodeKZL
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  BK940022  Blood and Plasma Warming Devices
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DUPACO
  SUBSTANTIALLY EQUIVALENT 2
FUTURE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 2
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
SEABROOK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 106
Detachment of device component 36
Kinked 35
Fitting problem 35
Material rupture 6
Device contamination with blood or blood product 3
Difficult or delayed activation 2
Device inoperable 2
Disconnection 2
Component(s), broken 2
Air leak 1
Restricted flowrate 1
Leak 1
Device Difficult to Setup or Prepare 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Buckled material 1
No Information 1
Total Device Problems 238

-
-