Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190002Device Name
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
Manufacturer
Shanghai Kohope Medical Devices Co., Ltd
Date Cleared
2019-09-12
(253 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kohope Medical Devices Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile Insulin Syringe for Single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Insulin Syringe for Single use with the callbration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.
The sterile Hypodermic needle for Single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Device Description
The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient.
Configuration: Piston, Plunger, Barrel, (Needle) for Hypodermic Syringe; Needle cover, Needle, Piston, Barrel, Plunger, End cap for Insulin Syringe; Protective cap, Needle tube, Adhesives, Needle hub for Hypodermic Needle.
Operation Mode: For manual use only.
Nozzle: Luer Slip, Luer Lock for Hypodermic Syringe and Hypodermic Needle; Fixed Needle for Insulin Syringe.
Volume/Sizes: Luer slip: 1,2,3,5,10,20,30,35,50,60(ml), Luer Lock: 1,2,3,5,10,20,30,35,50,60(ml), 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Syringe; 0.3, 0.5, 1(ml), 29G, 30G, 31G for Insulin Syringe; 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G for Hypodermic Needle.
Material: Plunger: polypropylene (PP); Barrel: polypropylene (PP); Piston: isoprene rubber; Hypodermic needle: polypropylene (PP), stainless steel; for Hypodermic Syringe; Needle cover: polypropylene (PP); Needle: stainless steel (SUS); Piston: isoprene rubber; Barrel: polypropylene (PP); Plunger: polypropylene (PP); End cap: polypropylene (PP); for Insulin Syringe; Protective cap: polypropylene (PP), Needle tube: stainless steel (SUS), Adhesives: epoxy resin, Needle hub: polypropylene (PP) for Hypodermic Needle.
Ask a Question
Page 1 of 1