A-A-54408
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Quantity |
Component |
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1 |
Ruler, Plastic, 15 cm. |
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1 |
Polypropylene Syringe, 5 l with 23 Gage by 1 inch needle. |
|
2 |
Polypropylene Syringes, Luer-Lock, 20 ml. |
|
1 |
Umbilical Catheter, 5 Fr, 14 Inches Long with 0.22 ml capacity. |
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1 |
Umbilical Catheter, 8 Fr, 14 Inches Long with 0.88 ml capacity. |
Blood transfusion set. The blood transfusion set shall consist of a piercing device, filter, housing, nylon filter, 60 inches of plastic tubing, 2-1/2 inches of natural rubber tubing on proximal end (next to filter), 4 inches of rubber tubing on distal end (next to needle adapter), needle adapter and a flexible aluminum control clamp.
Pyrogens, safety and biological tests. All rubber and plastic components shall be sterilizable, free from pyrogens in accordance with the USP, safe in accordance with the USP (nontoxic) and shall contain not more than 5 parts per million (ppm) of lead, barium and cadmium. The plastic shall meet the requirements of the United States Pharmacopeia (U.S.P.) for Class II plastics.
Material. Plastic tubing shall be transparent, colorless polyvinyl. The piercing device and needle adapter shall be fabricated from suitable rigid plastic. needles shall be fabricated of type 304 corrosion-resisting steel in accordance with ASTM Designation F899.
Sterility. Components and inside surfaces of the tray shall be sterile in accordance with the USP or AAMI guidelines. Sterility Assurance Level shall be 0.000001.
Expiration dating. The blood exchange-transfusion kit shall have an expiration date of at least 36 months. At time of shipment to the Government, at least 30 months of the expiration dating period shall remain on the item.
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