Heel Incision Device NEWBORN STERILE
McKesson - 16-PAHL2.5G1.0
Device Description
A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMK
Device Name: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class: 2
Physical State: A single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature).
Definition: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Device used to puncture skin.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Skin.
Regulation Number: 878.4850
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 20612479223404
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10612479223391
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 10612479223391
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 40612479223415
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479223404
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case