FKJ

Product Code: FKJ

Products Classified as FKJ

1901

Filter, Blood, Dialysis

Hemodialysis System And Accessories.

Total Product Life Cycle (TPLC) Devices

1901

Filter, Blood, Dialysis

Hemodialysis System And Accessories.

FDA Consensus Standards

• Filter, Blood, Dialysis [36802]: 21 CFR §876.5820 🔎
• Filter, Blood, Dialysis [37765]: 21 CFR §876.5820 🔎
• Filter, Blood, Dialysis [37766]: 21 CFR §876.5820 🔎

Pre-market Notifications for FKJ

K901734	SERIM RESIDUAL CHLORINE TEST KIT	SERIM RESEARCH CORP.
K820575	J.E.T. DIALYSIS SYSTEM	COMPUTER DIALYSIS SYSTEMS, INC.
K772040	TRANSDUCER PROTECTOR	TERUMO AMERICA, INC.

Global Unique Device Identification Database

• M1745100C2: Filter, Blood, Dialysis

Maude Adverse Events

DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A +INCL. BIC	B.BRAUN AVITUM AG	2017-05-16
DIALOG A + 1 BLOOD PUMP 120V	B. BRAUN AVITUM AG - MELSUNGEN	2017-03-07
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2017-01-25
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2017-01-17
DIALOG A + 1 BLOOD PUMP 120V	B. BRAUN AVITUM AG - MELSUNGEN	2016-12-14
DIALOG A + 1 BLOOD PUMP 120V	B. BRAUN AVITUM AG - MELSUNGEN	2016-11-15
MEDISYSTEMS	MEDISYSTEMS	2016-11-01
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-27
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-27
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-27
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-27
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-27
DIALOG+ HDF-ONLINE	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-19
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-10-05
DIALOG+ HDF-ONLINE INCL. AKKU/ABPM	B. BRAUN AVITUM AG - MELSUNGEN	2016-09-16
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-08-05
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-07-22
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-07-19
DIALOG + 120 V DF+ADIMEA+WAN-BSL	B. BRAUN AVITUM AG - MELSUNGEN	2016-06-29
DIALOG + 120 V DF+ADIMEA+WAN-BSL	B. BRAUN AVITUM AG - MELSUNGEN	2016-06-29
DIALOG + 120 V DF+ADIMEA+WAN-BSL	B. BRAUN AVITUM AG - MELSUNGEN	2016-06-29
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-06-27
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-04-20
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-02-22
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-01-26
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-01-25
DIALOG A + HE/BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-01-25
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-01-18
DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC	B. BRAUN AVITUM AG - MELSUNGEN	2016-01-18