FIF

Product Code: FIF

Products Classified as FIF

1855

Set, Dialysis, Single Needle With Uni-directional Pump

Hemodialysis System And Accessories.

Total Product Life Cycle (TPLC) Devices

1855

Set, Dialysis, Single Needle With Uni-directional Pump

Hemodialysis System And Accessories.

FDA Consensus Standards

• Set, Dialysis, Single Needle With Uni-Directional Pump [36802]: 21 CFR §876.5820 🔎
• Set, Dialysis, Single Needle With Uni-Directional Pump [36807]: 21 CFR §876.5820 🔎
• Set, Dialysis, Single Needle With Uni-Directional Pump [36809]: 21 CFR §876.5820 🔎
• Set, Dialysis, Single Needle With Uni-Directional Pump [36808]: 21 CFR §876.5820 🔎

Pre-market Notifications for FIF

K873279	8810 PUMP-PUMP SINGLE NEEDLE DEVICE	CD MEDICAL, INC.
K820173	COBE SINGLE-NEEDLE CONTROLLER #18-756	COBE LABORATORIES, INC.
K802230	BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP	CARDIO MED SUPPLIES, INC.
K801967	MEDCOMP FEMORAL VEIN CATHETER	MEDICAL COMPONENTS, INC.
K792174	MODEL DM 353 & DM-353-L SINGLE NEEDLE	EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K772147	GW 35 GUIDE WIRE	SORENSEN RESEARCH

Maude Adverse Events

DRAINAGE BAG	B BRAUN MEDICAL INC	2007-01-18
CRRT UF DRAINAGE BAG	B BRAUN MEDICAL, INC	2007-01-18
DRAINAGE BAG	B BRAUN MEDICAL, INC	2007-01-18
PRISMA CONTROL UNIT	GAMBRO DASCO	2006-03-30
		2006-03-30