510(k) K053645 ยท DWJ System, Thermal Regulating
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
| Applicant | Arizant Healthcare, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Dec 30, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.