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510(k) Data Aggregation
K Number
K231519Device Name
Revital Cady
Manufacturer
Date Cleared
2023-11-06
(165 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Revital Healthcare (EPZ) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.
Device Description
The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. lt is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch. The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back. The Syringe consist of four components i.e. 1. Barrel 2. Plunger 3. Gasket 4. S.S Clip The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres. The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger. The Syringe is supplied with a Hypodermic Needle is made of three components i.e. 1. Needle tube 2. Needle hub 3. Needle cap The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury.
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