Childrens Medical Ventures, LLC
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Childrens Medical Ventures, LLC makes
Children’s Medical Ventures, LLC manufactures the NeoPAP System, a neonatal non-invasive respiratory support device designed for infants requiring positive airway pressure therapy.
The NeoPAP System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Neopap System Ref K103410
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Childrens Medical Ventures, LLC, the earliest on 2014-04-29 and the most recent on 2014-05-28. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 28 May 2014 Z-2192-2014 Class I Terminated The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
- 29 Apr 2014 Z-1789-2014 Class II Terminated The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
Full distribution text
Frequently asked questions
How many devices does Childrens Medical Ventures, LLC have in the registry?
The registry currently lists 1 device for Childrens Medical Ventures, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Childrens Medical Ventures, LLC's devices?
Among its 1 most recently registered device, Childrens Medical Ventures, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Childrens Medical Ventures, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Childrens Medical Ventures, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Childrens Medical Ventures, LLC?
FDA recall records list 2 recalls initiated by Childrens Medical Ventures, LLC, the most recent initiated on 28 May 2014. 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 Childrens Medical Ventures, LLC in the registry?
The most recently registered devices listed for Childrens Medical Ventures, LLC include NEOPAP SYSTEM.