A-A-30099D
Plastic tray. The tray shall contain all of the components packed in the order of use. The tray shall not leak when filled to capacity and shall be constructed to maintain its size and shape to the point of use. The minimum thickness of the bottom of the tray shall not be less than 0.0305 mm. The base area of the tray with, respect to the total outside surface area, shall not be less than 22 percent. Type II tray shall be either compartmented or noncompartmented and shall be approximately 7.62 deep by 11 cm wide by 22 cm long. If compartmented the main compartment shall have a fluid capacity of at least 700 ml. Long side of tray shall have graduations which are visible from outside the tray.
For Type II kit, cleaning swabs (5 each) may be furnished in lieu of cotton/rayon balls, cleaning solution and forceps. Swab tip shall be approximately 3.8 cm in diameter and shall be premoistened with sufficient povidone-iodine solution to adequately prep patient. Swabs or absorbent balls shall be provided in a suitable separate container.
Lubricant. Lubricant shall be provided in a suitable container marked or labeled with contents. Labeling shall meet the requirements of the Federal Food, Drug, and Cosmetic Act.
Specimen container. Shall be supplied with label for patient’s name, room number, date, doctors name and instructions.
Examining gloves. Gloves shall be suitably packaged or folded to facilitate donning gloves without violating aseptic technique. The gloves shall be tested in accordance with ASTM designation D5151-90 or the lastest FDA glove adulteration watertight test procedure. Gloves shall be free from seams or welts in the palm or finger tip areas and shall conform to the human hand after not more than one minute wear. Refer to ASTM Designation D3578-91 for the metric conversion of glove sizes. Vinyl and plastic gloves shall be designated small, medium, large, or universal size.
Cleaning solution. Cleaning solution shall be 10% Povidone-Iodine solution USP and shall be furnished in a suitable container with labeling meeting the requirements of the Federal Food, Drug and Cosmetic Act
Syringe. For Type II, the syringe shall have a Luer taper tip with cap and shall be clearly and legibly graduated from 0 to 30 ml in 1 ml increments.
Catheter urethral. Should have an outside diameter of 5.0 cm (15 French) and shall be a Robinson red rubber catheter; sterile, 2 eyes, round tip, approximately forty one centimeters long.
Shelf life. Not less than 30 months (Type I and II) and 25 months (Type III and IV) of the expiration dating period shall remain at time of delivery to the government.
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