MEDSUN

MEDSUN - CX11C1

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QRL

Device Name: Multiple Use Blood Lancet For Single Patient Use Only

Device Class: 2

Physical State: Comprised of a single use blade attached to a solid, reusable base.

Definition: A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable 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 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 Id: 06934047902482

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