5 results
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6ms
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Sources: EU EUDAMED, US FDA
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019