Sterile infusion set for single use
Model: infusion set: GB8368 IS-V
infusion set: GB8368 IS-NV
Product structure: plastic protector for spike, spike, air-inlet, soft tube, drip chamber, flow regulator, fluid filter, and injection site for adding fluid drugâ?¦etc.
Product instruction: The products are made by medical polymer materials. Sterilized by EO gas; sterile, non-toxic, pyrogen free. The products are made by medical soft materials surface is sound and transparent.
Technical indication: in accordance with GB8368 and ISO8536-4.
Scope for use: The products are used for intravenous gravity infusion.
Sterile Vacuum blood collection tube for single use:
Sizes: 1ml, 2ml, 3ml;, 5ml, 10ml.
SPEC: non-additive, additive.
Product structure: test tube, piston, plastic cap.
Product instruction: The products are made by medical glass, or highly transparent medical plastic materials.
The products are matched with vacuum blood collection sets, and used as per the theory of negative pressure, and suck blood into the storage tube by the connecting tube, and can step the way of one vacuum blood collection needle with more storage tubes.
Technical indication: Additive dosage of the products are accurate, blood sample capacities are also accurate.
Scope for use: The products are used for collecting blood in clinic
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
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.
