FDA Device Entity Profile: ISOPURE CORP.

Known Identifiers & Locations

FEI Numbers 3013942511

Owner Operator Numbers 9042051

Locations Covered Louisville, KY, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3003768032	ISOPURE, CORP.	Louisville, KY, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0033-2012	Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system. Reason: Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.	2011-05-19	Terminated	View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.