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The device is indicated for use as a dispenser, measuring device, and fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to in all age groups.

The device is an enteral feeding syringe for single use. The devices are piston-style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and syringe cap. The device incorporates a female ENFit connector designed to be compatible only with enteral access devices or accessories. It has ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. The device is a disposable syringe made of the following components: 1. Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel. 2. Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled. 3. Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids. 4. Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.

This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below: | Name | Material | Material Specification | |--------------|-----------------------------------|------------------------------| | Needle tube | 304 stainless steel | SUS304 | | Needle hub | Polypropylene (PP) | R307Y | | Needle cap | Polypropylene (PP) | R307Y | | Hub colorant | Black Masterbatch | Carbon Black | | Lubricant | Medical Highly Activated Silicone | Highly Reactive Silicone Oil | | Adhesive | Ultraviolet adhesive | AA 3311 | The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (<24h).

The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals. The Blood Collection Needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is ¾" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that permits identification and acts as a seal integrity. The Safety Blood Collection Set is delivered sterile and is intended for single use only.