Devices

Device Recall RenalSoft Observational Study v.2.0

Model / Serial
version 2.0 - HD Modules, PD Modules and Medical Record Modules only
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
Product Description
Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Manufacturer
Baxter Healthcare Renal Div
1 Event
- Recall of Device Recall RenalSoft Observational Study v.2.0

Manufacturer

Baxter Healthcare Renal Div

Manufacturer Address
Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
Source
USFDA

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