Product classification
B1 Disposable Suction Oral Care Kit
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Details Introduction
- Product Description
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[Product Name] Disposable Suction Oral Care Pack
[Product Specifications] See product single packaging
[Main Structure Composition] Composed of oral suction tube (including brush head), medical examination gloves, disposable dressing tweezers, medical isolation pads, cotton balls, and tongue depressors. All instruments in the pack belong to Class I medical devices and are non-sterile. For single use. [Scope of Application] Used for oral cleaning and care in medical institutions.Serial Number
Accessories
Structure Composition
Classification Directory
Model Specification Configuration
B1
B2
B3
1
Oral Suction Tube (including brush head)
Oral Suction Tube (including brush head)Composed of sponge brush head, tube body, and connector; used in connection with negative pressure equipment and negative pressure drainage bags.Non-sterile.Sterilization or disinfection should be performed by the user institution according to the instructions before use (if applicable).
17-04-20
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2
Medical Examination Gloves
Made of polyethylene material. Has sufficient strength and barrier performance..Non-sterile, single use.
14-14-04
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3
Disposable Dressing Tweezers
Composed of a pair of overlapping blades. Made of polystyrene material.Non-sterile.Sterilization or disinfection should be performed by the user institution according to the instructions before use (if applicable). Not to be used under endoscopy.
02-05-02
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4
Medical Isolation Pad
Made of non-woven fabric and plastic composite, cut and sewn.Non-sterile, single use.
14-15-05
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5
Cotton Balls
Mainly composed of cotton. Used for cleaning skin and wounds. Does not contain disinfectants. Non-sterile, single use.
14-16-10
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6
Tongue Depressor
Made of wooden material. Non-sterile, single use.
07-01-01
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[Usage Method]
1. Open the packaging bag, wear examination gloves, and connect the machine end of the oral suction tube to the negative pressure device.
2. Place the patient end of the oral suction tube into the patient's mouth, using the sponge brush head to clean the patient's mouth and between the teeth. When starting to suction the liquid from the patient's mouth, block the pressure relief port to create a closed state in the tube, forming negative pressure, and suction the liquid.
3. Lay the isolation pad as needed, and use the dressing tweezers to pick up cotton balls to wipe the sputum around the lips (suitable for B2 and B3 types).
4. Use the tongue depressor to press down on the patient's tongue for better operation (suitable for B3 type).
5. After use, first close the negative pressure, then remove the oral suction tube.
[Contraindications, Precautions, Warnings, and Instructions]
1. Be sure to connect a waste liquid collection bag between the negative pressure source and the product and clean it in a timely manner to avoid waste liquid directly entering the negative pressure source equipment, which could damage the equipment. 2. It is recommended to adjust the negative pressure source within an appropriate range to ensure that excessive negative pressure does not cause harm to the patient.
3. If the product cannot suction during use, please immediately remove the product and perform relevant checks and cleaning. If it cannot be restored, please replace it with a new product. 4. This product is for single use only, dispose of after use. 5. Before use, please confirm the expiration date and check if the packaging and product are intact. Do not use if the product is damaged, expired, or the packaging is broken. 6. When not in use, keep the pressure relief port in the open state. 7. When the product is used for oral care, it is not suitable for agitated, mentally symptomatic, or critically ill patients with oral ulcers. For patients with clenched jaws, use an opener with two people if necessary. 8. During use, pay attention to the firmness of the connection between the brush head and the tube body. 9. This product is for single patient use only. 10. This product should be purchased and used under the guidance of medical personnel. 11. Use with caution for those allergic to sponge material.[Illustrations and Symbol Definitions]
Production Date
Validity Period
Do not reuse
Do not use if packaging is damaged[Storage and Transportation Conditions]
1. This product should be stored in a clean indoor environment at room temperature, with relative humidity not exceeding 80%, and free from corrosive gases, dry, well-ventilated. 2. During transportation and storage, prevent moisture, heat, direct sunlight, and heavy pressure, and do not freeze.
[Product Filing Certificate Number] Guinan Medical Device Filing 20240103
[Production Filing Certificate Number] Guinan Drug Supervision and Medical Device Production Filing 20210015
[Product Technical Requirement Number] Guinan Medical Device Filing 20240103
[Production Date] See product single packaging [Shelf Life] Two years
[Filer/Manufacturer and After-Sales Unit] Guangxi Yihe Medical Technology Co., Ltd. [Contact Information] Phone: 0771-6262566
[Address/Production Address] No. 146 Wuhua Avenue, ASEAN Economic and Technological Development Zone, Guangxi - Changgui ASEAN Science and Technology Park, Building 12
[Instruction Compilation Date] October 6, 2024
[Manual Version] A/0
Key words:
Hand Hygiene Disinfection | Skin and Mucous Membrane Disinfection
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