BD Plastipak Syringe Without Needle
BD MedicalThe Danby BuildingEdmund Halley RoadOxford Science ParkOxford, Oxfordshire, OX4 4DQtel: 44 (0)1865 748844fax: 44(0)1865 717313www.bd.comTECHNICAL DATA SHEETBD Plastipak Syringe without needleSterile, Single use, Latex Free1. General Information1.1 GeneralBD Plastipak syringes are used for general purpose injection and aspiration of fluids fromvials, ampoules and parts of the body below the surface of the skin. Perfusion syringes, 50mlsyringes, are designed for short term use in syringe pumps (active IIa devices) for theadministration of pharmaceuticals.The 50 ml Catheter Tip Syringes have a long tapered tipdesigned to aid in irrigation or for connection to non-ISO compatible Luer connections suchas nasogastric tubes.LUER SLIP SYRINGESReference 08691 ml1 ml1 ml1 ml1 ml1 ml2/ 2.5 ml5 ml10 ml20 ml20 ml30 ml50/ 60 ml50/ 60 ml100 ml50/ 60 mlDescriptionInsulin 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 adaptorLuer Lock AMBERScale GraduationInternational unitsInternational unitsInternational unitsInternational units0.01 ml0.01 ml0.1 ml0.2 ml0.5 ml1 ml1 ml1 ml1 ml1 ml2 ml1 mlThe content of this Technical data sheet can be changed without further notice.This document is electronically 048024024024050240Page 1 of 10
BD Plastipak Syringe without needle- Version October 2015LUER LOK SYRINGESReference CapacityDescription30118920 mlLuer Lok ScaleGraduation1 mlBox(units)60Case(units)24030062920 mlLuer Lok 1 ml12048030122930 mlLuer Lok 1 ml6024030086550/60 mlLuer Lok 1 ml6024030013750 mlPerfusion Luer Lok 1 ml5010030013950 mlPerfusion Amber Luer Lok 1 ml501003096281 mlLuer Lok 0.01 ml1008003096583mlLuer Lok 0.1ml2008003096495mlLuer Lok 0.2ml12550030091210mlLuer Lok 0.2ml1004001.2 Technical informationDEAD SPACE (maximum, w/o needle) (except for catheter tip syringes)SYRINGE SIZEDead Space1 ml0.07 l50ml0.20ml100ml0.20ml1.3 CertificationBDPRODUCTCODE(20-100 RTIFICATIONBecton Dickinson &Company LimitedDonore RoadDroghedaCo. LouthIrelandNSAI - CertificateMD 19.1609 I.S.EN ISO 13485:2012This document is approved electronicallyThis document can be changed without further notificationCEMARKINGNSAI NB no0050:CertificateN 252.156BD MANUFACTURINGSITEBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainPage 2 of 10
BD Plastipak Syringe without needle- Version October 2015BDPRODUCTCODE(1 to 10 173303174(1 ml LL)309628BDMANUFACTURERISOCERTIFICATIONBecton 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 :2008CertificateMD19.2305CEMARKINGBD MANUFACTURINGSITEAEMPS 0318:CertificateN 2000 060273 CPBecton Dickinson S.A. Camino de Valdeoliva, s/n.28750, San Agustin delGuadalix (Madrid) SpainAEMPS N. 2012 070013 EN - EN –ISO 13485:2013NSAI 0050:CertificateN 252.231NSAI ISO13485 :2012CertificateMD19.2305(3 to 10mlLL)309658309649300910300911300912Becton, Dickinsonand Company1 Becton DriveFranklin Lakes, NJ07417, USANSAI - ISO9001 :20008CertificateMD19.2305NSAI 0050:CertificateN 252.231Becton, Dickinson andCompanyRoute 7 & GraceWay,Canaan CT 06018USABD Singapore Branch, 30Tuas Avenue 2, Singapore639461Becton, Dickinson andCompanyRoute 7 & Grace Way,Canaan CT 06018USANSAI ISO13485 :2012CertificateMD19.23051.4 MaterialCOMPONENTMATERIALSYRINGEBarrels, plunger rodsPOLYPROPYLENEBarrel cat# 309628POLYCARBONATEStoppersLATEX FREE ELASTOMERLubricantMEDICAL GRADE SILICONE OIL, 0.25 mg/cm2AMBER syringes have the barrel colored to reduce U.V. light; for administration of light sensitive medicationsPACKAGINGWeb packagingInkBoxPOLYAMIDE/POLYETHYLENE, PAPER WITH MEDICAL GRADEPrinting InkHARD PAPERThis document is approved electronicallyThis document can be changed without further notificationPage 3 of 10
BD Plastipak Syringe without needle- Version October 20151.5 Material of concernMaterials of concern are chemicals or substances that have been identified as having thepotential to cause long term effects on humans or the environment.MATERIALDEHP/PhthalatesLatexBisphenol ASubstances of animalorigin BSE/TSEPolyvinyl(PVC)chlorideCOMMENTThe products do not contain di(2ethylhexyl) phthalate DEHP as CAS number 11781-7, EC number 204-211-0.The products do not contain natural latex.The products do not contain Bisphenol A.These devices utilize very small amounts of tallow or tallow derivatives (e.g.stearates in polymers). Per MEDDEV 2.4/1 Rev. 9 June 2010 and Directive2003/32/EC,such substances are not considered as derivatives of animal tissues forthe purpose of this rule which therefore does not apply.The products do not contain polyvinyl chloride-1.6 REACH informationBased on information available and BD’s continuous data collection efforts throughout thesupply chain, BD have not identified any chemicals in the articles and packaging with theProduct Numbers as referenced above, in an individual concentration above 0.1% weight byweight (w/w), which have been listed as SVHC and included in the "Candidate List"published by the European Chemical Agency (ECHA) on 28 October 2008, according to Art.59 (1, 10) of the Regulation (EC) N 1907/2006 (REACH). The substances published in suchlist are candidates for eventual inclusion in the List of Substances Subject to Authorization(Annex XIV of REACH).1.7 BiocompatibilityBD Medical products comply with the requirements of the standard for biocompatibility ofmedical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluationand Testing.1.8 SterilizationEthylene Oxide Sterilization following EN ISO 11135-1. ETO residues are withinapplicable regulations. All references excepting references below are sterilized with EO.Radiation Sterilization following EN ISO 11137-1 References sterilized with radiation:309628, 309658,300912, and 309649.1.9 Shelf lifeShelf life 5 yearsStore in dry and warm place and not exposed to strong light.This document is approved electronicallyThis document can be changed without further notificationPage 4 of 10
BD Plastipak Syringe without needle- Version October 20151.10 StandardsALL SYRINGES MEET THE FOLLOWING STANDARDS:EN 556-1EN 980EN 1041EN 1707 / ISO 594-2EN ISO 7886-1*EN 20594-1EN ISO 10993 seriesEN ISO 11135-1*EN ISO 11137-1*EN ISO 11137-2EN ISO 11737-1EN-ISO 11737-2EN ISO 11607-1EN ISO 11607-2EN ISO 13485EN ISO 14971EN ISO 15223-1Sterilization of Medical Devices-requirement for medical devices to belabeled “sterile”Graphical Symbols for use in the labeling of medical devicesTerminology, symbols and information provided with medical devices.Information supplied by the manufacturer with medical devicesConical fittings with a 6% (Luer) taper for syringes, needles and certainother medical equipment-Lock fittings (only applies to Luer Lock Syringes)Sterile hypodermic syringes for single useConical fittings with a 6% (Luer) taper for syringes, needles and certainother medical equipment-Part 1: General requirements (ISO 594-1:1986)Biological evaluation of medical devicesSterilization of health care products – Ethylene oxide – Part 1:Requirements for development, validation and routine control of asterilization process for medical devicesSterilization of health care products - Radiation. Part1.Requirements fordevelopment, validation and routine control of sterilization process formedical devicesSterilization of health care products – Radiation. Part2. Establishing thesterilization doseSterilization of medical devices – Microbiological methods – Part 1:Determination of a population of microorganisms on productsSterilization of medical devices- Microbiological methods – Part 2: Tests ofsterility performed in the definition, validation and maintenance of asterilization processPackaging for terminally sterilized medical devices – Part 1: Requirementsfor materials, sterile barrier systems and packaging systemsPackaging for terminally sterilized medical devices – Part 2: Validationrequirements for forming, sealing and assembly processesMedical Devices, Quality Management Systems, Requirements forRegulatory purposesMedical devices- Application of risk management to medical devicesMedical devices-Symbols to be used with medical devices labels, labelingand information to be supplied Part.1: General requirements*Some exceptions / exemptions may applyINSULIN GRADUATED SYRINGE ALSO MEETS ISO 8537* Sterile single-use syringes,with or without needle, for insulin.1.11 ClassificationClass I Sterile with a measuring function (syringes from 1 to 10 ml) Medical Deviceunder Rule 2, Annex IX of Medical Devices Directive 93/42/EEC as amended.Class IIa (syringes from 20 to 50 ml) Medical Device under Rule 2, Annex V andVII IX of Medical Devices Directive 93/42/EEC as amended.This document is approved electronicallyThis document can be changed without further notificationPage 5 of 10
BD Plastipak Syringe without needle- Version October 20151.12 GMDN codeGMDN code 47017: General purpose syringes.1.13 Good Manufacturing practicesThe entire manufacturing and testing processes are following the Good ManufacturingPractices as specified below Incoming raw materials are verified via material inspection and testing and oursuppliers are approved via our vendor management system. In addition to the automatic on-line inspections, in-process inspections are performedin addition to final product testing to ensure compliance with approved specifications. The manufacturing and testing details of each batch of product are recorded on abatch record 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 indesigning and manufacturing its products. BD reserves the right to use the internal change control procedure to change rawmaterial suppliers and production process1.14 Others The EU representative, for syringes which BD Manufacturer is Becton, Dickinsonand Company, 1 Becton Drive, Franklin Lakes, NJ 07417, USA, is Becton DickinsonDistribution Center, Laagstraat 57, B-9140 Temse -Belgium. Other syringes areproduced by a European manufacturer. Material Data Safety sheets are not required for this product Certificate of Food Contact (COMMISSION REGULATION (EU) No. 10/2011 ofJanuary 14th, 2011 concerning materials and plastic objects intended to get in touchwith foodstuffs) is not required as BD products are used for general purpose injectionand aspiration of fluids from vials, ampoules and parts of the body below the surfaceof the skin.2Packaging2.1 Packaging materialLABELS: according to European Medical Device directive, multilingualThis document is approved electronicallyThis document can be changed without further notificationPage 6 of 10
BD Plastipak Syringe without needle- Version October 20152.2 Example labelingManufacturer: San Agustin del GuadalixUnit packShelf boxShelf box labelThis document is approved electronicallyThis document can be changed without further notificationPage 7 of 10
BD Plastipak Syringe without needle- Version October 2015Manufacturer: DroghedaUnit packShelf boxThis document is approved electronicallyThis document can be changed without further notificationPage 8 of 10
BD Plastipak Syringe without needle- Version October 2015Shelf box labelManufacturer: Franklin LakesUnit packThis document is approved electronicallyThis document can be changed without further notificationPage 9 of 10
BD Plastipak Syringe without needle- Version October 2015Shelf boxShelf box labelThis document is approved electronicallyThis document can be changed without further notificationPage 10 of 10
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 300613 20 ml Eccentric cone 1 ml 120 480 301231 30 ml Eccentric cone 1 ml 60 240 300866 50/ 60 ml Eccentric cone 1 ml 60 240 3
SS-01T 1cc TB Syringe without needle, with luer slip SS-01T2516 1cc TB Syringe with 25G x d" removable needle SS-01T2609 1cc TB Syringe with 26G x s" removable needle SS-01T2713 1cc TB Syringe with 27G x 2" removable needle 3cc Syringes with Needle Style: Luer Lock Tip Graduations: 0.1cc (3cc total)
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Injekt 10 mL Eccentric Syringe 4606108V-02 1200 Injekt 10 mL Eccentric with 21G x 1½ in. Needle 4645103V-02 1200 Injekt 20 mL LL Syringe 4606736V-02 800 Injekt 20 mL Eccentric Syringe 4606205V-02 800 Injekt 20 mL Eccentric with 21G x 1½ in. Needle 800 INJEKT-F SYRINGE (Low Waste) Injekt-F syringe tip prevents dead space with minimal residual .
SASH Kits: 2 BD Prefilled Normal Saline Syringes, 1 Prefilled Heparin Lock Flush Syringe 306537: 5 mL Fill in 10 mL Syringe - 100 unit/mL . Hypodermic Needle: 50 per box, 500 per case: 305921: 27 G x 5/8 in. Needle: 25 G x 5/8 in. Needle: 305916: 25 G x 1 in. Needle: 305902: 23 G x 1 in. Needle: 305900: 22 G x 1 1/2 in. Needle:
till the syringe piston becomes soften, it is performed prior to use the product. Suck in the medicine solution into the syringe cylinder by pulling the plunger vertical axis in the syringe cylinder as needed. Take out the air bubble from the syringe cylinder by pushing the plunger forwardly vertically axis in the syringe cylinder.
Syringe Hypodermic 10ml luer slip 42% Syringe Hypodermic 20ml luer slip 18% Syringe Hypodermic 30ml luer slip 0% Syringe Hypodermic 50/60ml luer slip 1% Figure 1 Syringe volume by size- Nov 16 . Whilst there are no clear recommendations in the literature on when to use a luer slip vs. a luer lock syringe, the engagement with clinicians across .
Before you use ACTEMRA prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it. Do not remove the needle cap until you are ready to inject ACTEMRA. Do not try to take apart the syringe at any time. Do not reuse the same syringe. Parts of your ACTEMRA Prefilled Syringe (See Figure A).
Becton Dickinson and Company BD Medical A-One Business Centre Z.A. Vers-la-Pièce n. 10 CH-1180 Rolle Switzerland bd.com TECHNICAL DATA SHEET BD Plastipak syringes without needles and
