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510(k) Data Aggregation
K Number
K230080Device Name
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
Manufacturer
Yangzhou Medline Industry Co., Ltd.
Date Cleared
2023-07-07
(177 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Medline Industry Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Safety Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.
The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.
The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.
The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Connect base (ABS), Non-patient end needle tube (Stainless Steel SUS304), Rubber sleeve (Gather Isoprene Rubber), Needle Holder (PP).
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K Number
K170651Device Name
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Manufacturer
Yangzhou Medline Industry Co., Ltd.
Date Cleared
2017-08-02
(152 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Yangzhou Medline Industry Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.
The Sterile Disposable Syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
Device Description
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Needle is intended for manual and single use only, which consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size.
The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.
The Sterile Disposable Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Needle is intended for manual and single use only, which is compatible for use with a luer slip or luer lock syringe. The proposed device is available in variety combination of needle gauge and needle length.
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