Search Results
Found 1 results
510(k) Data Aggregation
K Number
K231558Device Name
SMB Luer lock disposable syringe
Manufacturer
Date Cleared
2024-01-12
(227 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SMB Corporation of India
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SMB Hypodermic Syringe is used to inject fluid into or withdraw fluid from the body. This device is for single use only.
Device Description
The SMB Luer lock disposable syringe is a standard Piston Syringe. It is a two-piece Syringe with male 6% luer lock connection. The Syringe is supplied with Hypodermic Needle having a female 6% luer hub. The Syringe and Needle are supplied sterilized by ETO gas. The device is single use device and non-pyrogenic. The device is available with 2ml Syringe and 23G Needle. A detailed description of Syringe and Needle is as follows: Syringe: The Syringe consists of hollow barrel with graduated scale and movable plunger. The barrel has a nozzle with a male luer lock connector that facilitates the connection with female luer lock hub of needle. The graduated scale on the barrel is indicated in the milliliters. The movable plunger is pulled to aspirate and pushed to inject the fluids into barrel. Needle: The Needle consists of Needle tube, Needle cap. The Needle tube is attached to the Needle hub and the Needle hub is attached to the syringe by luer lock system. A cap is provided to protect Needle sharps protection as well as prevention of injury.
Ask a Question
Ask a specific question about this device
Page 1 of 1