A-A-54404A
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Component |
Quantity |
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Type I |
Type II |
Type III |
Type IV |
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Containers (tubes), specimen with a capacity of at least 7 cc. numbered with attached screw-on caps and label or space for writing. Tubes to stand upright in depressions provided. |
3 |
3 |
3 |
3 |
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Sterilization indicator |
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1 |
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(*1) A suitable valve which performs the functions of the stopcock may be substituted |
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(*2) May be two-piece with range of 55 cm minimum |
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(*3) Not required with valve |
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* |
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Tray shall be recessed to receive and retain components in position, and in the sequence of use. Needle shall be furnished with suitable protectors.
The lumbar puncture kit shall be packaged so as to maintain sterility of the tray and contents until manually opened.
Material. The needle shall be fabricated from austenitic corrosion resistant steel in accordance with ASTM Designation F899.
Sterility. Components shall be sterile in accordance with the USP or AAMI guidelines. Sterility assurance level shall be 0.000001.
Biocompatibility. Plastic component material in contact with bodily tissue or fluids shall meet the requirements of the USP for Class II plastic.
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