Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No

Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Code information: Lot Code: LOT: 63721010001,63721010003,63721040002,63721050 002,63721060001,63721070001,63721070002, 63721070003,63721070004,63721070006,63721080 001,63721080002,63721080003,63721080004, 63721080005,63721090001,63721090003,63721090 004,63721090005,63721100001,63721110001, 63721110002,63721110003,63721120002,63721120 003,63721120004,63722010001,63722020002, 63722030001,63722030002,63722030003,63722030 004,63722040002,63722040004,63722050001, 63722050002,63722050003,63722060002,63722060003,63722060006,63722070002,63722070004, 63722070005,63722070006,63722080003,63722080 005,63722080006,63722090003,63722100003, 63722120003,63722120004,63723010001,63723020 001,63723020002,63723050001,63723060001, 63723070001,63723070002,63723070003,63723080 002,63723080003,63723090002,63723090003, 63723090004,63723100003,63723100004,63723110 001,63723110003,63723120002

Distribution pattern: U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.