Lancing Device

Lancing Device
McKesson - 50005-0400-05

Device Description

A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QRK

Device Name: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Device Class: 2

Physical State: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base.

Definition: A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Used to puncture the 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 Identifiers

Device Id: 40612479265736

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479265725

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 20612479265725

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: 10612479265711

Device Type: Unit of Use

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