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510(k) Data Aggregation
K Number
K032141Device Name
SECUMAX BLOOD COLLECTION SYSTEM
Manufacturer
Date Cleared
2004-01-28
(201 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
TIGER MEDITECH INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SecuMax™ Blood Collection System is a sterile and single-use package consisting of a sterile Luer holder with a sterile Luer adapter to hold Exel hypodermic needles during venipuncture. The entire device will be disposed as a unit in a sharps container.
Device Description
The SecuMax ™ Blood Collection System is a single-use sterile blood collection system. There are three main components in the package, i.e., sterile hypodermic needle, sterile Lucr adapter, and sterile Luer type holder. Special N-typed ergonomic lucr adapter can eliminate the collection angle by placing the nearly parallel with the arm. The special design luer adapter can be used with any size of hypodermic needle. Push-off Luer holder is designed to fit N-typed luer adapter. The hypodermic needle used is Exel International disposable hypodermic needles with 510K # 861153.
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