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Panels › Cardiovascular › Product code DWJ · Class 2

System, Thermal Regulating

Regulation 870.5900

5510(k)s in 12 months (161 all time)
3recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DWJ

DateFirm and productCodeLinked 510(k)
Aug 9, 2012Kimberly-Clark Corporation
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated fo
Terminated
DWJK033021
May 24, 2012Cincinnati Sub-Zero Products Inc
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the
Terminated
DWJNone listed
Feb 7, 2012Cincinnati Sub-Zero Products Inc
Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled w
Terminated
DWJNone listed
Feb 7, 2012Cincinnati Sub-Zero Products Inc
Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device,
Terminated
DWJNone listed
Sep 1, 2011Cincinnati Sub-Zero Products Inc
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135
Terminated
DWJK101148
Jul 27, 2011Cincinnati Sub-Zero Products Inc
WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convec
Terminated
DWJK101148
Jul 14, 2011Cincinnati Sub-Zero Products Inc
Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature.
Terminated
DWJNone listed
Jul 1, 2011Cincinnati Sub-Zero Products Inc
ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a pat
Terminated
DWJK811742
Jul 1, 2011Cincinnati Sub-Zero Products Inc
ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patie
Terminated
DWJK811742
Mar 30, 2011Cincinnati Sub-Zero Products Inc
115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperatu
Terminated
DWJK101589
Mar 1, 2010Arizant Inc
Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. To provide power to pressure infusers.
Terminated
DWJK053645
K060865
Mar 1, 2010Arizant Inc
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids.
Terminated
DWJK053645
K060865
Mar 1, 2010Arizant Inc
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245. Intended to warm blood, blood products and liquids
Terminated
DWJK053645
K060865
Mar 1, 2010Arizant Inc
Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Manag
Terminated
DWJK053645
K060865
Feb 4, 2010Cincinnati Sub-Zero Products Inc
FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
Terminated
DWJK942599
Oct 29, 2009Cincinnati Sub-Zero Products Inc
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after su
Terminated
DWJK942599
Jun 1, 2005Arizant Inc
Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been pr
Terminated
DWJK001149
K913734
May 17, 2005AMF Support Surfaces Inc
Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress)
Terminated
DWJNone listed
Feb 3, 2005Smiths Medical ASD, Inc.
Equator Forced Air Convective Warming System, Reference Number EQ 5000
Terminated
DWJK011907
Jan 26, 2005MEDIVANCE INC.
Arctic Sun Temperature Management System
Terminated
DWJK002577
K010338

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