Clinical Evaluation Report for delivery set.docVIP

CLINICAL EVALUATION for 【Medical Fluid Delivery Set with Accessories】 Model Types: (Class IIa, Sterile) ? I.V. Administration Sets ? Blood Transfusion Sets ? Enteral Extension Sets ? Irrigation Tubing Sets ? Extension Sets: IE ? Injection Port: IPN Doc. Number: CER-2013**** Revision: A Date of report: 2013**** This clinical evaluation report is evaluated by below evaluator Internal as qualification Position: QA Engineering Name: Signature: Internal as qualification Position: QA Manager Name: Signature: Internal as qualification Position: General Manager Name: Signature:  1. General Details 1) Product Name : Medical Fluid Delivery Set with accessories 2) Manufacturer : ABC Company *****************************, Taiwan, R.O.C. TEL: 886- FAX: 886- E-mail: 2. Description of the device and its intended application 2.1. Description of the device Model Type Description IV Administration Set Drip chamber, delivery tubing, roller clamp, MLL Blood Transfusion set Drip chamber, delivery tubing, roller clamp, stopcock, MLL Enteral Extension Set FLL, delivery tubing, slide clamp, enteral connector Irrigation Tubing Set Spike, delivery tubing, roller clamp, silicon tubing, flush tube Extension set and inject port Delivery tubing, clamp, FLL, MLL, T-Site The device consists of a conventional chamber, extension tubing, clamp, standard female luer conical fitting, male luer conical fitting, and vented end cap. The end cap can be removed for connecting to a male luer fitting of a different device for administering fluids. The name and material for each component is listed as follows: Item Component Name Material/Trade name 1 Extension tubing PVC 2 Roller Clamp ABS 3 Female conical fitting (FLL) PVC 4 Sidle Clamp HDPE 5 Drip Chamber PE, ABS, PVC, ABS/Nylon 6 Male conical fitting (MLL) PVC 7 Line Filter Hydrophilic membrane 8 Check Valve PC 9 End cap LDPE 10 Unit packaging pouch Paper  2.2. Intended Application ABC medical fluid delivery sets are the