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Devices
2008T Hemodialysis Delivery System
Model / Serial
2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su;
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
2008T, Hemodialysis Delivery System || Product Indicated for acute and chronic dialysis therapy.
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
1 Event
Recall of 2008T Hemodialysis Delivery System
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Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
Manufacturer Address
Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
Language
English
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