1、6- 9 2-6-97 A-A-53 07 8 16 July 1987 COMMERCIAL ITEM DESCRIPTION TUBE AND SYRINGE, STOMACH (Adult, Lavage, Edlich, Disposable, 34 Fr) The General Services Administration has authorized the use of this Commercial Item Description. This commercial item description covers an adult tube and syringe used
2、 for flushing the stomach. Salient characteristics. General. Shall be a disposable, adult stomach tube and syringe consisting of a 34 Fr tube and a 5-ounce catheter tip syringe. Material. The syringe shall be fabricated from polypropylene. The tube shall be fabricated from transparent polyvinyl chlo
3、ride. The syringe adapter and slide clamp shall be fabricated from rigid plastic. The syringe plunger tip shall be fabricated from rubber. The plastic components coming in contact with the fluid shall meet the requirements of the Pharmacopeia of the United Sta-tes for Class IV plastics (USP). Those
4、rubber and plastic components coming in contact with the fluid shall contain not more than 5 parts per mj.llion (ppm) total lead, barium and cadmium when tested in accordance with the Physico-Chemical Tests in the USP. Characteristics. Shall consist of a 5-ounce syringe, a 34 Fr + 1 Fr stomach tube
5、with a length of 36 inches +4,-1 inch and-a slide clamp. have an adapter designed to attach to the syringe in a leak- tight fit. The proximal end of the tubing shall AMSC N/A FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; di s t. r i but i on i. s uni. im i te d. r THIS DOCUMENT CON
6、TAINS 5 PAGES. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-Ai53078 b5 9999974 0924389 b COMMERCIAL ITEM DESCRIPTION A-A-53078 The syringe shall have aubyraduations every 5 milliliters (m1)up to the 140 ml mark. Each LO ml shall be numbered and
7、longer than the subgraduations, There shall also be a numbered graduation at each ounce with subgraduations at each 1/4 ounce, the subgraduations . The ounce graduations shall be longer than The plunger tip shall be lubricated with pharmaceutical grade silicone lubricant, The plunger shall make a go
8、od seal between the barrel and the plunyei: such that there 5halP be no leakage past the plunger in either direction. The plunger tip shall have a minimum o? two rings making contact with the barrel. The distal tip ring shall accurately indicate the syringe fluid volume on the barrel. The plunger ti
9、p shall be of a color which clearly contrasts with the syringe barrel for maximum visibility. The syringe shall have an integral catheter tip and an outside flange designed to provide a finger grip and also function as an anti-roll device, The catheter tip shall be one inch Long and taper from a nom
10、inal 0.450 to 0,500 inch. Th tubing shall have 4 non-opposiny eyes within 6 inche6 of the iatal, tip, The eyes shall measure nominally 1/4 inch on the shout axis and 3/8 inch on the long axis. The tubing ahal be a nominal 5/16 inch on the inside diameter. The tubing aha11 have insextion depth marks
11、at 18, 22, 26 and 30 inches ?mm the distal tip. Each eye shall have the same cross sectional area as the tubing. Feedorn ?rom foreicrn matter. The fluid path shall be free rom chips, dirt or other foreign matter. Florkmunship. The tube and syringe assemblies shall be free from defects which detract
12、from its appearance or impair its serviceability. - Unit. Package (PG) , One package containing twenty Individually packaged tube and syringe assemblies, as oj 0 r s-3 1.0 _lll_ Classification of Defects Ma j o f: 3.02 Sharp edges or burrs at eyes or closed end of tube, 3 02 Poor fit of syringe cath
13、eter tip to adapter on tube resulting in separation or leakage. 103 Lack of seal at plunger tip-barrel interface resilting in leakage past: plunger tip. 104 Graduation marks on syringe not: clear, or removable by rubbing. 1 Qd Purrs at c.8theter tip of syringe. Contractor certification, The contract
14、or shall certify that tl-6 product offered meets the salient characteristics of this c3ssc;Sptiori anti eonforms “to the producers own drawings, cpeciEications, atanclards, and quality assurance practices. The Gsvwnment reserves the right to require proa of such confoxmance prior to first delivery a
15、nd thereafter as may be otfierwise provided for under the provisions o the contract . RguPntsry requirements. by this document has been determined by the U,S. Food and Drug Administration to be under its jurisdictionr the offemr/contraetor sfai:! complyr and be reqonsible for compliance by its subco
16、ntractors/uppliersr with the requirements o% th6 Federal Food, DEug and Cosmetic Act, as amended, and regulatims promulgat.eG thereunder, In addition, the sfEerer/cor3twaefor kiall. comply, and be responsible for compliance by its aubcontractors/suppliers, with the requirements of all sther applicab
17、le Federal, State, and local statutes, ordinancesr and regulations, Federal Food, Druq and Cosmetic Act. If the product covered 4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-53078 65 7777774 0027372 b = COMMERCIAL ITEM DESCRIPTION A-A-53078 R
18、ecovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580 to the maximum extent practical. Preservat.ion, pa-ck-acfinq, packinq, labelinq, and markinq. Unless otherwise specified, preservation, packaging, and packing shall be to a degree
19、of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment from the supply source to the receiving activity, pliic reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Inte
20、rmediate and exterior package quantities and labeling and marking shall be as specified in the contract and/or order. NOTE: The following National Stock Number is covered by this do cum ent : NSN ITEM IDENTIFICATION 6515-00-435-8959 TUBE AND SYRINGE, STOMACH, Adult, 34 Fr, Lavage, Edlich, Disposable
21、, 20s Ordering data (Intermediate/exterior package quantities and labeling and marking must be specified in the contract and/or order). MILITARY INTERESTS: Preparing Activit-y : Custodia.ns: DoD-PB Army - MD Navy - MC Air: Force - 03 Agent: DL A- D M CIVIL AGENCY COORDINATING ACTIVITIES: VA-OSS PH S FDA- HPQAS Project No. 6515-3942 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
