510(k) K142702 ยท DWJ System, Thermal Regulating
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
| Applicant | Medivance, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Dec 18, 2014 |
| Received | Sep 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142702
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2024 | Medivance Inc. Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C Open, Classified |
DWJ | None listed |
| Nov 8, 2017 | Bard Medical Division Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads:
Description, Catalog Number
a) Intrepid ArcticGel Small Pad Kit, 31705I
b) Intrepid ArcticGel Medium Pad Kit, 31707I
c) Intrepid ArcticGel Large Pad Kit, Terminated |
DWJ | None listed |
| Oct 16, 2017 | C.R. Bard, Inc. Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad.
Terminated |
DWJ | None listed |
| Jun 2, 2017 | C.R. Bard, Inc. Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 Open, Classified |
DWJ | None listed |
| Aug 5, 2016 | C.R. Bard, Inc. Medivance ArcticGel Neonatal Pad
The pad is designed to fit into an incubator and provide whole body cooling for patients. Terminated |
DWJ | None listed |
| Mar 4, 2016 | C.R. Bard, Inc. BARD ArcticGel Pads
Product Usage:
The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temp Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.