[Product Name] Disposable Dialysis Care Pack
[Specification and model] HLB-A type
[Name of Registrant/Name of Production Enterprise] Jilin Fran Medical Technology Co., Ltd. [Address] Bingsan Road, Changde New District, Changchun, Jilin Province
[Production address] Bing30 Road, Changde New District, Changchun, Jilin Province [Contact information] 0431-81180431
[Production License No.] Ji Shi Yao Jian Xi Production License No. 20150048
[Medical Device Registration Certificate No.] JiXZZ 20212140382 [Product Technical Requirements No.] JiXZZ 20212140382
[Main structure and composition of the product]
Basic configuration: medical gauze dressing, disposable pad
Selection and configuration: degreased cotton balls, cotton swabs, cotton rolls, degreased gauze bandages, medical examination pads, iodophor cotton balls, alcohol cotton balls, tweezers, rubber examination gloves, PE examination gloves, tourniquet, wound patches, infusion patches, iodophor cotton swabs, alcohol cotton swabs, sterile patches, medical adhesive tapes, trays, and wrapping cloths
[Product performance]
Specifications and dimensions of components: The specifications and dimensions of medical devices with medical device registration certificates or filing certificates comply with the provisions of the registration certificates or filing certificates,
Other devices comply with the provisions of Table 1 in the product technical requirements.
Appearance: The appearance of each component of the nursing package should be upright, with a clean and smooth surface, and there should be no stains, damages, or other phenomena.
Sterile: The product should be sterile.
Residual amount of ethylene oxide: should not exceed 10 μ G/g.
For other performance indicators, please refer to the "Technical Requirements for Disposable Dialysis Care Pack Products".
[Scope of Application] Used by medical institutions for pre and post dialysis care.
[Instructions for Use] Open the packaging directly and use according to nursing requirements.
[Contraindications] None
[Precautions, Warnings, and Indicative Notes]
- Before use, first check whether the packaging is intact, and confirm the packaging label, production date, and sterilization validity period, and use it within the validity period;
- This product is sterilized and sterile with ethylene oxide, and it is strictly prohibited to use if the packaging is damaged;
- This product is disposable and disposed of in accordance with the Medical Waste Management Regulations after use. Reuse is prohibited;
- Please refer to the certificate of conformity or minimum inner packaging for product specifications, quantities, production batch numbers, production dates, and sterilization dates.