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The ESM-UBT device is intended to provide temporary control of postpartum uterine bleeding when conservative management is warranted.

The Every Second Matters - Uterine Balloon Tamponade ("ESM-UBT") device is a single use product that consists of the kitting of 510(k)-cleared or off-the-shelf ("OTS") class I exempt components. The kit also contains an antiseptic prep pad that is marketed under an OTC monograph and is intended for use as an accessory with and during the assembly of the class I medical device components of the ESM-UBT device: - Urinary catheter - Luer lock valve - Condom - Syringe - Elastic O-ring - Catheter holder - Antiseptic (povidone iodine) prep pad The components will not be modified from their packaged state, and the entire kit will be re-labeled as the ESM-UBT device. The device is assembled in an ISO certified clean room using the Foley urinary catheter, Luer lock valve, condom, and a green elastic O-ring. The assembled condom-catheter is inserted into the bleeding uterus through the cervical opening. Upon placement within the uterine cavity, the balloon on the Foley catheter is inflated first with 15 mL of saline. This small balloon helps secure the catheter inside the uterus. One port on the Foley catheter is used for the syringe to inject saline into the small balloon, whereas the other port is used to inflate the condom balloon with saline. This condom balloon should be inflated until tamponade occurs as evidenced by bleeding cessation. The maximum fill volume of 500 mL was verified in bench tests. The device should be fixed to the thigh at the end using the catheter holder.