■ Product Name / Approval Number: Short-term Use Tracheal and Bronchial Tube Catheter / Jane 21-4822
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 3 years from the manufacturing date
■ Manufacturer: Inseong Medical Co., Ltd., 168 Industrial City, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province, South Korea
■ Manufacturing License Number: License No. 838
■ The accompanying document is provided in electronic format on the following website:
http://www.insungmedical.co.kr/customer/userguide/
■ Date of Instruction Manual: November 17, 2021 (rev. ~)
■ This product is a disposable sterilized medical device, and reuse is strictly prohibited.
[Information in the Attached Document]
■ Intended Use
For short-term use, the product is inserted through the oral cavity to secure the airway, serving as a tube or catheter.
■ Directions for Use
① Select the appropriate size of the product for the patient.
② Open the patient's mouth and insert the product as shown in the diagram below.
■ Precautions Before Use
① Check the expiration date.
② Verify the integrity of the packaging, including any damage or opening.
③ Before use, thoroughly understand the instructions for use and precautions.
④ Quickly remove the product when the patient's spontaneous breathing returns to prevent vomiting.
⑤ Check for damage, changes in quality, and choose the appropriate size for the patient.
■ Precautions During Use
a. Warning
① Do not use if the sterilized product's packaging is opened, damaged, or compromised.
② This product is a single-use medical device, and reuse is strictly prohibited.
b. General Caution
① Familiarize yourself with the instructions for use before use, and only trained medical professionals should use the product.
② Prohibit the use if there is damage, changes in quality, or any alterations in the product before use.
③ Select the product size that fits the patient.
■ Storage Conditions: Store at room temperature, avoiding direct sunlight, within the range of 1~35℃.
■ Packaging Unit: 1EA
■ Manufacturer (Importer): Inseong Medical Co., Ltd., 168 Industrial City, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province
■ Manufacturing License Number: License No. 838
■ This product is a disposable sterilized medical device, and reuse is strictly prohibited.
■ Date of Instruction Manual: November 17, 2021
■ Product Name / Approval Number: Short-term Use Tracheal and Bronchial Tube Catheter / Jane 21-4822
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 3 years from the manufacturing date
■ Manufacturer: Inseong Medical Co., Ltd., 168 Industrial City, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province, South Korea
■ Manufacturing License Number: License No. 838
■ The accompanying document is provided in electronic format on the following website:
http://www.insungmedical.co.kr/customer/userguide/
■ Date of Instruction Manual: November 17, 2021 (rev. ~)
■ This product is a disposable sterilized medical device, and reuse is strictly prohibited.
[Information in the Attached Document]
■ Intended Use
For short-term use, the product is inserted through the oral cavity to secure the airway, serving as a tube or catheter.
■ Directions for Use
① Select the appropriate size of the product for the patient.
② Open the patient's mouth and insert the product as shown in the diagram below.
■ Precautions Before Use
① Check the expiration date.
② Verify the integrity of the packaging, including any damage or opening.
③ Before use, thoroughly understand the instructions for use and precautions.
④ Quickly remove the product when the patient's spontaneous breathing returns to prevent vomiting.
⑤ Check for damage, changes in quality, and choose the appropriate size for the patient.
■ Precautions During Use
a. Warning
① Do not use if the sterilized product's packaging is opened, damaged, or compromised.
② This product is a single-use medical device, and reuse is strictly prohibited.
b. General Caution
① Familiarize yourself with the instructions for use before use, and only trained medical professionals should use the product.
② Prohibit the use if there is damage, changes in quality, or any alterations in the product before use.
③ Select the product size that fits the patient.
■ Storage Conditions: Store at room temperature, avoiding direct sunlight, within the range of 1~35℃.
■ Packaging Unit: 1EA
■ Manufacturer (Importer): Inseong Medical Co., Ltd., 168 Industrial City, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province
■ Manufacturing License Number: License No. 838
■ This product is a disposable sterilized medical device, and reuse is strictly prohibited.
■ Date of Instruction Manual: November 17, 2021