EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
FDA 510(k) clearance K060537 · decided 2006-06-08
Clearance details
- K-number
- K060537
- Device name
- EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
- Applicant
- Enginivity, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-02-28
- Decision date
- 2006-06-08
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kittery, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood sol recall (Z-1385-2019) | Vyaire Medical | 2019-06-26 |
| enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy wi recall (Z-1386-2019) | Vyaire Medical | 2019-06-26 |
| enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CART recall (Z-1972-2012) | Vital Signs Devices, a GE Healthcare Company | 2012-07-09 |
| enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, recall (Z-3040-2011) | Vital Signs Devices, a GE Healthcare Company | 2011-08-19 |
| Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care recall (Z-2380-2010) | Vital Signs Inc | 2010-09-03 |
| Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 9 recall (Z-2008-2009) | Enginivity LLC | 2009-09-04 |