Merit Medical Systems, Inc.

Lot number F622787

Cardiovascular Devices

2

No

United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.

Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

Lot numbers: G543419, G625228, and MR604366.

Gastroenterology-Urology Devices

2

Yes

Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

Lot numbers: G543417, MR604365, and MR607896.

Gastroenterology-Urology Devices

2

Yes

Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

Lot numbers: G543416, G625227, MR604361, MR604362, MR604363, MR604364, and MR607895.

Gastroenterology-Urology Devices

2

Yes

Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 || Used for drainage of bile within the biliary system.

Lot numbers: G543418, MR604367, and MR607897.

Gastroenterology-Urology Devices

2

Yes

Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Used for drainage of bile within the biliary system.