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510(k) Data Aggregation
K Number
K223480Device Name
Medipoint Blood Lancets
Manufacturer
Date Cleared
2023-01-13
(56 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Medipoint Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
Device Description
Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.
The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.
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