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510(k) Data Aggregation
K Number
K242622Device Name
Sterile Lancets for Single Use
Manufacturer
Ningbo Caremed Medical Products Co., Ltd.
Date Cleared
2024-10-28
(55 days)
Product Code
QRK, ORL
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Ningbo Caremed Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Lancets for Single Use is intended for capillary blood sampling.
Device Description
The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.
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