ACCORDING TO THE FOLLOWING STANDARDS:
ISO 80369-7
ISO 7886-1
ISO 7886-2 (COMPATIBLE WITH PUMP’S SETTING BD PLASTIPAK)
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
0Transparent syringe with needle for infusion systems.
TL108NASingle-use 50/60ml Luer lock cone syringe
Pump AdjustmentCompatibile B.D. Plastipak*
Box/Pcs50 (UDI-DI 08033481792098)
Carton/Pcs300 (UDI_DI 08033481792104)
*There is no business agreement or any other type of agreement between I.M.I. Snc and Becton & Dickinson. The BD Plastipak 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
LABEL:IMI
VOLUME:50/60ML
NOZZLE:LUER LOCK
MOUNTED NEEDLE14G
BARREL:TRANSPARENT POLYPROPYLENE ATOXIC
PLUNGER:POLYPROPYLENE ATOXIC ADDED OF MASTER BATCH WHITE COLOR
SEAL GASKET DOUBLE RING:MADE OF SYNTHETIC POLYSOPRENE BLACK COLOR
SCALE:MARKED EACH ML IN BLU 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.
