Manual blood lancing device, single-use

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Linear Medical Pty Ltd

Klass:

Class IIa

Tillverkad av:

SteriLance Medical Suzhou Inc no 68 Litanghe Road, Xiangcheng, Suzhou, 215133 China

Terapiområde:

61578 - Manual blood lancing device, single-use

Terapeutiska indikationer:

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.

Bemyndigande status:

A

Tillstånd datum:

2017-08-22