FKR

Product Code: FKR


Products Classified as FKR

1909Subsystem, ProportioningHemodialysis System And Accessories.

Total Product Life Cycle (TPLC) Devices

1909Subsystem, ProportioningHemodialysis System And Accessories.

FDA Consensus Standards

Subsystem, Proportioning [36807]21 CFR §876.5820 🔎
Subsystem, Proportioning [36809]21 CFR §876.5820 🔎
Subsystem, Proportioning [36808]21 CFR §876.5820 🔎

Pre-market Notifications for FKR

K140571NXSTAGE PUREFLOW SLNXSTAGE MEDICAL, INC.
K111174NXSTAGE PUREFLOW SLNXSTAGE MEDICAL, INC.
K080919NXSTAGE PUREFLOW SLNXSTAGE MEDICAL, INC.
K060296NXSTAGE DIALYSATE PREPARATION MODULENXSTAGE MEDICAL, INC.
K043436NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269NXSTAGE MEDICAL, INC.
K850756AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSTRAVENOL LABORATORIES, S.A.
K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSSARTORIUS FILTERS, INC.
K810605CHEMATIC BICARBONATE DIALYSATE SYSTEMTRIMEDYNE, INC.
K810127GAMBRO BICARBONATE MODULE, BCM-10GAMBRO, INC.
K802465BICARB-O-MATE HEMODIALYSIS SOD. BICARB.RENAL SYSTEMS, INC.
K800772MOD. DM-357 BICARBONATE RETROFIT KITEXTRACORPOREAL MEDICAL SPECIALITIES, INC.

Global Unique Device Identification Database

M535NX200011A0Subsystem, Proportioning
M535NX200010D0Subsystem, Proportioning

Maude Adverse Events

NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2019-08-29
PUREFLOW DIALYSATE CONCENTRATENXSTAGE MEDICAL, INC.2019-08-16
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2019-05-03
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2018-02-22
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2018-02-20
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2017-04-27
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2017-03-03
SYSTEM ONE WITH PUREFLOW SLNXSTAGE2014-05-15
SYSTEM ONE WITH PUREFLOW SLNXSTAGE2014-05-15
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