ACCORDING TO THE FOLLOWING STANDARDS:
ISO 594-1
ISO 594-2
ISO 7886-1
ISO 7886-2 (COMPATIBLE WITH PUMP’S SETTING TERUMO 50)
ISO 10993
UNI EN ISO 11135
UNI EN ISO 556
EUROPEAN PHARMACOPOEIAE
EUROPEAN DIRECTIVE 93/42 CEE
I DISPOSITIVI MEDICI E I DOCUMENTI ASSOCIATI SONO RISERVATI ESCLUSIVAMENTE AD OPERATORI SANITARI
0M series
Opaque syringe for infusion systems with needles
ML90NASingle-use 50/60ml Luer lock cone syringe
Pump AdjustmentCompatibile Fresenius Injectomat*
Box/Pcs50 (UDI-DI 08033481792272)
Carton/Pcs300 (UDI-DI 08033481792289)
*There is no business agreement or any other type of agreement between I.M.I. Snc and Fresenius SE & Co KGaA. The Fresenius Injectomat brand is only used for descriptive purpose to ensure correct use of the device.
N° identificazione CE: 0373
Technical datas
N° IDENTIFICATION CE:0373
NUMBER OF THE CERTIFICATE: QPZ-1931-20
CLASS:IIa
CND / EMDN CLASSIFICATION:A020102020101
N° REGISTRATION REPERTORY D.M. :59510 (Italian registration)
LABEL:IMI
VOLUME:50/60ML
NOZZLE:LUER LOCK
MOUNTED NEEDLE14G
BARREL:ATOXIC POLYPROPYLENE ADDED OF MASTER BATCH ORANGE COLOR
PLUNGER:POLYPROPYLENE ATOXIC ADDED OF MASTER BATCH WHITE COLOR
SEAL GASKET DOUBLE RING:MADE OF SYNTHETIC POLYSOPRENE BLACK COLOR
SCALE:MARKED EACH ML IN BLUE COLOR FOR DRYING PROCESS BY UV LED
SILICONIC OIL: MEDICAL FLUID
PRIMARY PACKAGE:BLISTER OF MEDICAL PAPER AND COUPLED FILM
SECONDARY PACKAGE:BOX OF TRIPLE CARTON RECYCLABLE x 50 PCS cm 38.0x24.5x19.5
OUTSIDE CARTON:TRIPLE CARTON RECYCLABLE x 300 PCS cm 60.0x39.0x49.5
STERILIZATION:BY ETHYLENE OXYDE
SHELF LIFE:5 YEARS
DELIVERY:ON PALLETT 120x80x210 INCLUDING 16 OUTSIDE CARTONS
MANUFACTURE:ACCORDING TO A QUALITY SYSTEM THAT ACCOMPLISHES ANNEX V° OF DIRECTIVE 93/42/CEE
NOTE: SYRINGES ARE PVC FREE, LATEX FREE. ALL USED SUBSTANCES ACCOMPLISH WITH REGULATION EC 1907/2006 REACH
