Uterine Balloon Tamponade
Intended use:
Uterine balloon tamponades (UBT) are medical devices that apply pressure to the uterus to reduce blood loss, stabilize the woman undergoing PPH, and reduce the need for surgical interventions and blood transfusions. The balloon is inserted into the uterus, filled with saline solution or sterile water (warm solution or water recommended to avoid hypothermia) to effectively tamponade to occur rapidly to stop the bleeding. This is a sterile and single-use device.
Product description
Balloon:
Material: medical grade elastomer, thermoplastic elastomer or medical grade silicone
Capacity: 500 ml – 1,000 ml filling capacity before balloon stretch. Volume should be adjustable depending on uterine size and bleeding
Shape: Diameter 80 mm and cylindrical shape
Thickness: Thin-walled for low expansion pressure requirement
Stretch capacity: minimum 2000 ml
Filling mechanism:
The balloon is filled with a syringe or through a gravity-based bag system. The filling needs to be stoppable by a one-way valve, a clamp or a closure tap to ensure pressure control, and there needs to be a quick mechanism to drain the balloon.
Filling time- the time it takes to fill the balloon should be specified by the supplier.
Indwelling time to be specified by the supplier.
No fluid leakage through any part of the device such as the balloon, stopcock etc. during insertion and inflation procedure.
Inflates uniformly without rupture
Syringe, if applicable:
Rapid instillation component
Luer lock Syringe, volume 60 ml
Sterile, for single use
Tubing:
Material: Translucent, flexible tube
Length: At least 16cm
Diameter: > CH22
Graduated scale or markings
Material: PVC latex-free
Sterilization method: EO (ethylene oxide) or gamma radiation
Shelf life: at least 36 months or more based on material and packaging.
Packaging and labeling:
Packaging: Single use products separately packed in sterile packaging.
Labeling: must include the device name, lot number, expiration date, CE mark with Notified Body number, Manufacturer´s name.
Supply with:
IFU in English.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year. OR US FDA 510(K) clearance
Classification:
Classified under EU MDR 2017/745 as Class IIb device. CE mark accompanied by the Notified Body's identification number
Quality, safety & product standards:
ISO 13485 Medical devices -Quality management systems
ISO 14971 Medical devices – Application of risk management to medical devices
ISO 10993 tested - Biocompatibility of medical devices to ensure they are safe for human use.
ISO 11135:2014 – Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
Intended use:
Uterine balloon tamponades (UBT) are medical devices that apply pressure to the uterus to reduce blood loss, stabilize the woman undergoing PPH, and reduce the need for surgical interventions and blood transfusions. The balloon is inserted into the uterus, filled with saline solution or sterile water (warm solution or water recommended to avoid hypothermia) to effectively tamponade to occur rapidly to stop the bleeding. This is a sterile and single-use device.
Product description
Balloon:
Material: medical grade elastomer, thermoplastic elastomer or medical grade silicone
Capacity: 500 ml – 1,000 ml filling capacity before balloon stretch. Volume should be adjustable depending on uterine size and bleeding
Shape: Diameter 80 mm and cylindrical shape
Thickness: Thin-walled for low expansion pressure requirement
Stretch capacity: minimum 2000 ml
Filling mechanism:
The balloon is filled with a syringe or through a gravity-based bag system. The filling needs to be stoppable by a one-way valve, a clamp or a closure tap to ensure pressure control, and there needs to be a quick mechanism to drain the balloon.
Filling time- the time it takes to fill the balloon should be specified by the supplier.
Indwelling time to be specified by the supplier.
No fluid leakage through any part of the device such as the balloon, stopcock etc. during insertion and inflation procedure.
Inflates uniformly without rupture
Syringe, if applicable:
Rapid instillation component
Luer lock Syringe, volume 60 ml
Sterile, for single use
Tubing:
Material: Translucent, flexible tube
Length: At least 16cm
Diameter: > CH22
Graduated scale or markings
Material: PVC latex-free
Sterilization method: EO (ethylene oxide) or gamma radiation
Shelf life: at least 36 months or more based on material and packaging.
Packaging and labeling:
Packaging: Single use products separately packed in sterile packaging.
Labeling: must include the device name, lot number, expiration date, CE mark with Notified Body number, Manufacturer´s name.
Supply with:
IFU in English.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year. OR US FDA 510(K) clearance
Classification:
Classified under EU MDR 2017/745 as Class IIb device. CE mark accompanied by the Notified Body's identification number
Quality, safety & product standards:
ISO 13485 Medical devices -Quality management systems
ISO 14971 Medical devices – Application of risk management to medical devices
ISO 10993 tested - Biocompatibility of medical devices to ensure they are safe for human use.
ISO 11135:2014 – Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $15.00 |
