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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.

The NeatNick Heel Safety Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants for subsequent diagnostic testing.

The NeatNick Heel Safety Lancet is a single use, blood sampling device with a sterile blade that are used by medical professionals to obtain a blood sample from the feet of neonates and infants for diagnostic purposes. The NeatNick Lancet incorporates an integral sharps injury prevention feature that also prevents reuse of the lancet. The NeatNick Lancet has been in commercial distribution since 2006. NeatNick Lancets are available in two configurations (Preemie and Full Term) are intended to be used by medical professionals to obtain a blood sample for diagnostic testing. The lancets consist of a stainless steel blade overmolded with low density polyethylene (LDPE) which protects the blade until use and functions as a sterile barrier. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-6. Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility. The lancet is classified as Class II. The lancet is currently in commercial distribution in the United States and Canada. Since commercial distribution of the current lancets began, there have been no design changes.

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.

The Facet Lancet is a sterile, disposable single used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

The Facet Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients. The lancet is available in two needle sizes, 30 gauge and 33 gauge. Facet lancets are intended to be used by diabetic patients to obtain a blood sample for assistance in self-monitoring of their blood glucose levels. The lancets consist of a 30G or 33G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.

The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancets consist of a 28G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.

The CareFine Pen Needle™ is intended for use with a pen injector device for the subculaneous injection of insulin

CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and the blue needle shield will be offered in 8mm length. CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length. The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization. The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needle family to include blue colored inner needle shield to distinguish the 8mm needle length. The intended use for the modified device remains the same as the predicate device.

The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.

CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, and 12.7mm). CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length. The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization. The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length. It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™. The intended use for the modified device remains the same as the predicate device.

The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.

CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, 8mm, and 12.7mm). CareFine™ Pen Needles are sterile (EtO terminal sterilization), non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterility barrier and tamper evidence seal. The peel-away label is pre-printed with information, which includes the lot number and needle gauge and length. The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.