TECHNICAL DATA SHEET Plastipak Syringes Without Needles .

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comTECHNICAL DATA SHEETBD Plastipak syringes without needles andBD General Syringes without needleSterile, Single Use, Latex free1. General Information1.1 GeneralBD Plastipak syringes are used for general purpose injection and aspiration of fluids from vials,ampoules and parts of the body below the surface of the skin. Perfusion syringes, 50ml syringes,are designed for short term use in syringe pumps (active IIa devices) for the administration ofpharmaceuticals. The 50 ml Catheter Tip Syringes have a long tapered tip designed to aid inirrigation or for connection to non-ISO compatible Luer connections such as nasogastric tubes.DEAD SPACE (maximum, without needle) (except for catheter tip syringes)SYRINGE SIZEDead Space1 ml0.07 l50ml0.20ml100ml0.20ml

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016LUER SLIP 7300605309654Capacity1 ml1 ml1 ml1 ml1 ml1 ml2/ 2.5 ml5 ml10 ml20 ml20 ml30 ml50/ 60 ml50/ 60 ml100 ml60mlDescriptionInsulin 40 I.U.Insulin 100 I.U.Insulin 100 I.U.Insulin 40 I.U.Central coneCentral coneCentral coneCentral coneEccentric coneEccentric coneEccentric coneEccentric coneEccentric coneCatheter tipCatheter tip with Luer adaptorSlip tipScale GraduationInternational unitsInternational unitsInternational unitsInternational units0.01 ml0.01 ml0.1 ml0.2 ml0.5 ml1 ml1 ml1 ml1 ml1 ml2 ml1 mlBox ase 0160Scale Graduation1 ml1 ml1 ml1 ml1 ml1 ml1 ml0.01 ml0.1ml0.2ml0.2ml0.2ml1 mlBox (units)60120606050504010020012510010060Case (units)240480240240100100160800800500400400240LUER LOK city20 ml20 ml30 ml50/60 ml50 ml50 ml60ml1 ml3ml5ml10ml10ml50/ 60 mlDescriptionLuer Lok Luer Lok Luer Lok Luer Lok Luer Lok PerfusionLuer Lok Perfusion AmberLuer Lok Luer Lok Luer Lok Luer Lok Luer Lok Luer Lok Luer Lok AMBER*305959 will be preferred to supply to European customers as this catalogue number of 10ml Luer Lok Plastipakis manufactured in Europe.This document is approved electronicallyThis document can be changed without further notificationPage 2 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.2 09653309654BDMANUFACTURERBecton Dickinson &Company LimitedDonore RoadDroghedaCo. LouthIrelandISOCERTIFICATIONNSAI - CertificateMD 19.1609 I.S. ENISO 13485:2012Becton DickinsonS.A. - Camino deValdeoliva, s/n.28750, San Agustindel Guadalix (Madrid)SpainAENOR –N. ER0264/1994 – ISO9001:2008;Becton, Dickinsonand Company1 Becton DriveFranklin Lakes, NJ07417, USANSAI - ISO9001 :20008CertificateMD19.2305CE MARKINGNSAI NB no0050: CertifícateN 252.156BD MANUFACTURINGSITEBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainAEMPS 0318:Certifícate N 2000 06 0273CPBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainNSAI 0050:Certifícate N 252.231Becton, Di be changed without further notificationPage 6 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20161.12 Good Manufacturing practicesThe entire manufacturing and testing processes are following the Good Manufacturing Practicesas specified below Incoming raw materials are verified via material inspection and testing and our suppliersare approved via our vendor management system. In addition to the automatic on-line inspections, in-process inspections are performed inaddition to final product testing to ensure compliance with approved specifications. The manufacturing and testing details of each batch of product are recorded on a batchrecord which is retained in accordance with our document control procedures BD operates a system of Internal and external audits to maintain compliance BD confirms that it will continue to adhere to relevant international standards in designingand manufacturing its products. BD reserves the right to use the internal change control procedure to change raw materialsuppliers and production process1.13 Others The EU representative, for syringes which BD Manufacturer is Becton, Dickinson andCompany, 1 Becton Drive, Franklin Lakes, NJ 07417, USA, is Becton DickinsonDistribution Center, Laagstraat 57, B-9140 Temse -Belgium. Other syringes are producedby a European manufacturer. (Material) Safety Data Sheets are not required for this product Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 of January14th, 2011 concerning materials and plastic objects intended to get in touch withfoodstuffs) is not required as BD products are used for general purpose injection andaspiration of fluids from vials, ampoules and parts of the body below the surface of theskin.This document is approved electronicallyThis document can be changed without further notificationPage 7 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 20162. Packaging2.1 Packaging materialLABELS: according to European Medical Device directive, multilingual2.2 Example labelingLegal Manufacturer and manufacturing site: San Agustin del GuadalixExample Unit pack cat.no 301355Example Shelf box label cat.no 301355This document is approved electronicallyThis document can be changed without further notificationPage 8 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box graphicsThis document is approved electronicallyThis document can be changed without further notificationPage 9 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Legal Manufacturer: Drogheda/ Manufacturing site San Agustin del GuadalixExample Unit pack cat.no 300867Example Shelf box label cat.no 300867This document is approved electronicallyThis document can be changed without further notificationPage 10 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box graphicsThis document is approved electronicallyThis document can be changed without further notificationPage 11 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Legal Manufacturer: Franklin Lakes, Manufacturing site CanaanExample Unit pack cat.no 309628Exmaple Shelf box label cat.no 309628This document is approved electronicallyThis document can be changed without further notificationPage 12 of 13

Becton Dickinson and CompanyBD MedicalA-One Business CentreZ.A. Vers-la-Pièce n. 10CH-1180 RolleSwitzerlandbd.comPlastipak syringes without needles TDS version March 2016Shelf box ----------------------end of ----------This document is approved electronicallyThis document can be changed without further notificationPage 13 of 13

The 50 ml Catheter Tip Syringes have a long tapered tip designed to aid in . 300185 2/ 2.5 ml Central cone 0.1 ml 100 800 302187 5 ml Central cone 0.2 ml 100 400 302188 10 ml Eccentric cone 0.5 ml 100 400 301183 20 ml Eccentric cone 1 ml 60 240 3006