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510(k) Data Aggregation
K Number
K212846Device Name
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Manufacturer
Date Cleared
2022-08-30
(357 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Jichun Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.
Device Description
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.
The device is delivered in the following configurations:
Needle Gauge: 18,19,20,21,22,23,24,25,26,27,28,29,30G
Needle Length: 1/6"-1 1/2"
Syringe Volume: 1,2,3,5,10,20,30,50,60,100 ml
Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:
Needle cap: PP
Needle tube: Stainless Steel
Needle hub: PP
Barrel: PP
Plunger stopper: Isoprene rubber
Plunger: PP
Ink: Black
Lubricant: Silicone oil
Adhesive: Epoxy resin
Colorant: PP masterbatch
The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours).
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