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Artificial insemination tube CK-80

Class II medical devices

Classification code:

6813

Product specification:

【Production license No】Liaoning food and drug supervision equipment production license No. 20180016

【Medical device registration certificate No】Liaoning Machinery registration 20172130208

【Product technical requirement No】Liaoning Machinery registration 20172130208

Product performance and main structure:

The main performance indexes are as follows:

1)The product is sterile and the period of validity is two years;
2)The product has no acute systemic toxicity;
3)The product should be cytotoxic;
4)The product has no hemolytic reaction;
5)Other technical indexes shall meet the technical requirements for artificial insemination tube.

Structure:

Artificial Insemination Catheter It is composed of a guiding catheter (MT-3082H B1220), catheter base, catheter tip (MT-3082H B1220) and outer sleeve.

The application scope of this product:

The product is used for artificial insemination. It is used for inserting semen into the uterine cavity through the vagina.

Contraindications:

This product is not suitable for acute inflammation of the reproductive tract and other conditions unsuitable for artificial insemination.

Precautions, warnings, and suggestive description:

1)The product is used by trained professionals;
2)This product is disposable and needs to be destroyed after use;
3)It needs to be used immediately after unpacking;
4)Do not use if the package is damaged;
5)Do not use if foreign matter is found in the package;
6)During the operation, it is forbidden to touch the catheter with hands or unsterilized matters;
7)After using this product, it should be treated as waste according to the regulations of the hospital or environmental protection department.

Label, Identified graphics, symbol compilation:

Label, Identified graphics, symbol compilation

Instructions:

1)This product is used by clinicians with the corresponding qualification;
2)According to the technical specifications, patients need to take the proper position and prepare for the vagina and cervix;
3)It is necessary to open the package according to the aseptic operation specifications, and then connect the product with a suitable syringe;
4)It is necessary to suck the sperm suspension into the Artificial Insemination Catheter and syringe;
5)Inject the sperm suspension into the appropriate part of the female reproductive tract;
6)Withdraw from Artificial Insemination Catheter;

Storage, transportation conditions, and methods:

1)The product needs to be stored in a dry and ventilated place. At the same time, it is necessary to prevent heavy pressure to avoid product deformation.
2)During the transportation of this product, it is necessary to prevent heavy pressure, direct sunlight and rain, and snow.

Service life:

The product is valid for two years after the sterilization date.