510(k) K060865 ยท DWJ System, Thermal Regulating
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
| Applicant | Arizant Healthcare, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Apr 24, 2006 |
| Received | Mar 30, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2018 | 3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500
The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, th Terminated |
DWJ | None listed |
| Jan 23, 2018 | 3M Company - Health Care Business 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700
The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temp Terminated |
DWJ | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.