Enginivity, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Enginivity, LLC makes
Enginivity, LLC manufactures intravenous (IV) fluid warming systems, including the EFLOW IV Fluid Warmer (Model 100), disposable cartridges (Model 200), and an AC power supply (Model 120). These devices are designed to maintain and deliver warmed IV fluids to patients, reducing the risk of hypothermia during infusion.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The portfolio is authorised for commercial distribution in the United States.
Catalogue
Eflow Iv Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 And Eflow Ac Power Supply, Model 120 Ref K060537
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Enginivity, LLC, initiated on 2009-03-23. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 23 Mar 2009 Z-2008-2009 Unclassified (pre-2012) Terminated 1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration.
2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).
Full distribution text
- 23 Mar 2009 Z-2008-2009 Unclassified (pre-2012) Terminated 1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration.
2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).
Frequently asked questions
How many devices does Enginivity, LLC have in the registry?
The registry currently lists 1 device for Enginivity, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enginivity, LLC's devices?
Among its 1 most recently registered device, Enginivity, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Enginivity, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Enginivity, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Enginivity, LLC?
FDA recall records list 1 recall initiated by Enginivity, LLC, the most recent initiated on 2009-03-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Enginivity, LLC in the registry?
The most recently registered devices listed for Enginivity, LLC include EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120.