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510(k) Data Aggregation
K Number
K223314Device Name
Disposable Blood Lancets
Manufacturer
Date Cleared
2023-01-25
(89 days)
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
Device Description
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.
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K Number
K223313Device Name
Disposable Safety Lancets
Manufacturer
Date Cleared
2023-01-23
(87 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The product is used to obtain capillary blood samples from fingertip in a home. The device contains a sharp injury protection feature.
Device Description
The Disposable Safety Lancets consists 7 parts, include a trigger, plastic handle, out shell, back cover, spring, protective cap and needle. The models of the Disposable Safety Lancets are 21G; 23G; 26G; 28G; 30G. The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The device contains a sharp injury feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. And once activated, the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. Used Gamma sterilization, and are products for single use.
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