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)
Top companies in DWJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2012 | Kimberly-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 |
DWJ | K033021 |
| May 24, 2012 | Cincinnati 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 |
DWJ | None listed |
| Feb 7, 2012 | Cincinnati 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 |
DWJ | None listed |
| Feb 7, 2012 | Cincinnati 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 |
DWJ | None listed |
| Sep 1, 2011 | Cincinnati 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 |
DWJ | K101148 |
| Jul 27, 2011 | Cincinnati 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 |
DWJ | K101148 |
| Jul 14, 2011 | Cincinnati 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 |
DWJ | None listed |
| Jul 1, 2011 | Cincinnati 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 |
DWJ | K811742 |
| Jul 1, 2011 | Cincinnati 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 |
DWJ | K811742 |
| Mar 30, 2011 | Cincinnati 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 |
DWJ | K101589 |
| Mar 1, 2010 | Arizant 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 |
DWJ | K053645 K060865 |
| Mar 1, 2010 | Arizant 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 |
DWJ | K053645 K060865 |
| Mar 1, 2010 | Arizant 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 |
DWJ | K053645 K060865 |
| Mar 1, 2010 | Arizant 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 |
DWJ | K053645 K060865 |
| Feb 4, 2010 | Cincinnati Sub-Zero Products Inc FilteredFlo Cardiac Blanket.
The device is used to distribute heated air around a patient (for patient warming). Terminated |
DWJ | K942599 |
| Oct 29, 2009 | Cincinnati 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 |
DWJ | K942599 |
| Jun 1, 2005 | Arizant 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 |
DWJ | K001149 K913734 |
| May 17, 2005 | AMF Support Surfaces Inc Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress) Terminated |
DWJ | None listed |
| Feb 3, 2005 | Smiths Medical ASD, Inc. Equator Forced Air Convective Warming System, Reference Number EQ 5000 Terminated |
DWJ | K011907 |
| Jan 26, 2005 | MEDIVANCE INC. Arctic Sun Temperature Management System Terminated |
DWJ | K002577 K010338 |
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