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The MICROLET®NEXT 2 Lancing Device is used with the disposable MICROLET®NEXT Lancet to obtain capillary blood samples.

The proposed MICROLET®NEXT 2 Lancing Device falls under multiple Use Blood Lancet for Single Patient Use Only category. The proposed MICROLET®NEXT 2 Lancing Device is a pen-like instruments to be used with the compatible MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing.

Lancet: The lancet is intended for capillary blood sampling. Lancing device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)

Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years. Lancing Device: Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.

The Facet Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.

Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.

It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.

The lancing device is a mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The lancing device is used with commercially available, sterile, standard square shaft blood lancets. The lancing device is for use only on a single patient.

The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of. For use only on a single patient in a home setting. Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components: (1)TD-5010 Lancing Device (2) Alternative Site Testing (AST) Cap

"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device" The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. "Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.

"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device" "Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home. "Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation. "Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings. Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges. "Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients. Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes. After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use. The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth. Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.

The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.

LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.

Disposable Sterile Lancet: The lancet is intended for capillary blood sampling. Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.

Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850). The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device. The intended users include healthcare personnel, patients and lay users. The lancet is provided sterile. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the lancet is 5 years.