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Butterfly Blood Collection Set. EO STERILIZATION Single Blister Package Specification: 21G, 23G, 25G, CUSTOMIZED MOQ 100K Sterile Pack, Single use only Color coded for easy identification of needle sizes Ultra-sharp needle tip minimizes patient discomfort More comfortable double wings design, easy operation Customized sizes available 510K approved CE approved ISO
Standard Needle EO STERILIZATION Single Blister Package MOQ 200K Specification : 18G---30G Sterile blister pack, single use only ultra-sharp needle tip minimizes patient discomfort color coded for easy identification of needle sizes compatible with standard syringes customized sizes available 510K CE ISO
Safety Huber Needle Features and Benefits Sterile pack, single use only. Needle-stick prevention, safety assured. Special needle tip design to prevent rubber fragment contamination. Luer connector, equipped with needleless connector, heparin cap, Y three-way. Chassis sponge design for a more comfortable application. High pressure resistant central line with 325 P.S.I Two holes connector optional. MDR 2017/745 USA FDA 510K Refer Standards ISO 10555-6:2015 Intravascular catheters - Sterile and single-use catheters Part 6: Subcutaneous implanted ports. ISO 8536-4: 2010 Infusion equipment medical use- Part 4: Infusion Sets for single use, gravity feed. ISO 23908:2011 Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood Samplings. ISO 7864:2016 Sterile Hypodemic Needles for Single-use requirements and test methods. ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices requirements and Test methods. ISO 80369-7: 2016 Small - bore connectors for liquids and gases in healthcare applications. Part 7: Connectors for intravascular or hypodermic applications. ISO 10993-7:2008 Biological Evaluation of Medical Device - Part 7: Ethylene Oxide Sterilization Residuals.
Pre-filled Normal Saline Flush Syringe Refer Standards ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. ISO 80369-7:2016 Small -bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications. USP Bacterial Endotoxins Test. USP Particulate Matter in Injections. USP PH. USP Sterility Tests. USP Heavy Metals USP Plastic Packaging Systems and Their Materials of Construction. ISO 10993-18: 2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
Insulin Syringe EO Sterilization Refer Standards ISO 9626: 1991 + AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices. ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin. ISO 10993-7:2008 Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals. ASTM F 1140/F 1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages. USP 37-NF 32 Bacterial Endotoxins Limit. ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process. ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Safety Slide Insulin Syringe EO Sterilization Refer Standards EN ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin. EN ISO 9626:1991 / AMD. 1: 2001 Stainless steel needle tubing for the manufacture of medical devices AMENDMENT 1. ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials. ASTM F1140/F1140M -13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. USP 37- NF32 2014: U.S. Pharmacopeia National Formulary.
Safety Insulin Pen Needle EO Sterilization Packaging Config : TBD Features and Benefits: Sterile pack, single use only. Caina patented product. Color coded for easy identification of needle sizes. Ultra-sharp needle tip minimizes patient discomfort. Needle stick prevention, safety assured. Unique needle lubrication process, most comfort injection. Mini design for easy carrying. Red indication for activation. All materials are latex & DEHP free.