510(k) K060537 ยท LGZ Warmer, Thermal, Infusion Fluid
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
| Applicant | Enginivity, LLC, Kittery ME, US |
| Decision | Substantially Equivalent, Jun 8, 2006 |
| Received | Feb 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060537
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | None listed |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | None listed |
| Jul 9, 2012 | Vital Signs Devices, a GE Healthcare Company enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL
100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY,
MODEL 120).
The Enginivity enFlow TM IV Fluid Warmer is intended Terminated |
LGZ | None listed |
| Aug 19, 2011 | Vital Signs Devices, a GE Healthcare Company enFlow IV Fluid Warmer Part number 980105VS;
(510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120)
Intended for warming blood, blood Terminated |
LGZ | None listed |
| Sep 3, 2010 | Vital Signs Inc Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids. Terminated |
LGZ | None listed |
| Sep 4, 2009 | Enginivity LLC Model 100 enFlow Fluid/Blood Warmer
Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156
The device is a medical point-of-care device designed to warm blood and IV fluids. Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.