2-part syringe - 2part syringe...― en iso 11737-1 ― en iso 13485 ― iso 14644-1 ― iso 14698-1...
TRANSCRIPT
HOSP
ITAL
PRO
DUCT
S
2-PART SYRINGESTERILE, SINGLE-USE FOR IMMEDIATE
INJECTION OR BLOOD COLLECTION
PRODUCT DATA SHEET
2
PRODUCT COMPLIANCE• CE-marked, Class I Medical Devices, Rule 1, UMDNS: 13929
• Complies with the following norms, directives, and regulations:
― EN 556-1
― EN 1707
― ISO 7886-1
― EN ISO 10993-1
― EN ISO 10993-4
― EN ISO 10993-5
― EN ISO 10993-7
― EN ISO 10993-10
― EN ISO 10993-11
― EN ISO 11135
― EN ISO 11737-2
― EN ISO 11138-1
― EN ISO 11138-2
― EN ISO 11607-1
― EN ISO 11607-2
― EN ISO 11737-1
― EN ISO 13485
― ISO 14644-1
― ISO 14698-1
― EN ISO 14971
― EN 15986
― EN 20594-1
― EN 62366
• Labels contain 26 languages
MANUFACTURING DETAILSLegal manufacturer: Guangdong Kindly Medical Device Group Co., Ltd.Country of origin: China
STERILIZATION AND SHELF LIFESterilization Single-use only Shelf life
EtO (Ethylene oxide) 5 years
2-PART SYRINGE S T ERIL E , S INGL E-USE FOR IMMEDI AT E IN JEC T ION OR BLO OD C OL L EC T ION
• Clear barrel for precise volume reading• Smooth plunger motion along entire length of barrel• Large finger grips for secure handling• Latex-free, BPA-free, DEHP-free, PVC-free• Available in centric or eccentric tip • For use immediately after filling; not intended to contain medicine for an
extended period of time
Medical DevicesClass I
UMDNS: 13929Rule 1
0123
3
MATERIALS USED
DEHP-free BPA-free
Latex-free PVC-free
PRODUCT RANGE OVERVIEWReference code Description Volume Type Scaling Max. graduation Dead spaceSY2-2SC-EC 2 part syringe 2 ml Luer Slip 2 ml CENTRIC 0,1 ml 2,4 ml ≤ 0,055 ml SY2-5SC-EC 2 part syringe 5 ml Luer Slip 5 ml CENTRIC 0,2 ml 5,8 ml ≤ 0,061 ml SY2-5ESC-EC 2 part syringe 5 ml Luer Slip 5 ml ECCENTRIC 0,2 ml 5,8 ml ≤ 0,061 ml SY2-10ESC-EC 2 part syringe 10 ml Luer Slip 10 ml ECCENTRIC 0,5 ml 11 ml ≤ 0,061 ml SY2-20ESC-EC 2 part syringe 20 ml Luer Slip 20 ml ECCENTRIC 1 ml 24 ml ≤ 0,081 ml
PACKAGING DETAILSBox Quantity (pcs) Outer box
Inner box Outer box Net weight (kg) Gross weight (kg) Length (mm) Width (mm) Height (mm)
SY2-2SC-EC 100 2500 6,65 9,90 600 405 375SY2-5SC-EC 100 2000 8,54 12,00 605 400 465SY2-5ESC-EC 100 2000 8,54 12,00 605 400 465SY2-10ESC-EC 100 1200 8,39 11,00 395 405 605SY2-20ESC-EC 100 800 9,26 11,85 605 410 465
Languages 26 languages on all levels of packaging:
English (EN), Bulgarian (BG), Czech (CS), Danish (DA), German (DE), Greek (EL), Spanish (ES), Estonian (ET), Finnish (FI), French (FR), Croatian (HR), Hungarian (HU), Italian (IT), Lithuanian (LT), Latvian (LV), Dutch (NL), Norwegian (NO), Polish (PL), Portuguese (PT), Romanian (RO), Russian (RU), Slovakian (SK), Slovenian (SL), Serbian (SR), Swedish (SV), Turkish (TR)
Transport conditionsClosed and dry
Storage conditionsOpen the packaging only immediately before use to guarantee sterility.
BarrelMaterial: Ethylene-Polypropylene, Copolymer
PlungerMaterial: Polyethylene (PE)
Nipro Hospital Products division is part of Nipro Corporation Japan, a leading global healthcare company established in 1954. With over 33.000 employees worldwide, Nipro serves the Medical Device, Pharmaceutical, and Pharmaceutical Packaging industries.
From preparation to administration, Nipro Hospital Products has a comprehensive portfolio of disposable medical equipment for hospital and ambulatory use.
Nipro Hospital Products is one of the world’s largest manufacturers of high quality needles and infusion products, producing over 11 billion needles annually. With a global network of 6 manufacturing plants, Nipro Hospital Products continues to advance high quality products known for their safety and ease of use.
BECAUSE EVERY LIFE DESERVES AFFORDABLE CARE
Nipro Medical Europe : European Headquarters, Blokhuisstraat 42, 2800 Mechelen, BelgiumT: +32 (0)15 263 500 | F: +32 (0)15 263 510 | [email protected] | www.nipro-group.com
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Label details
Individual unit Inner box Outer box
Product name
Product size
Quantity (pieces) —
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