Comfort Cough A10006

GUDID 08809517011064

This COMFORT COUGH (SICC2001) is composed of body part, connection tube, and power cable, providing positive pressure gradually and then turning it into negative pressure fast, to make high expiratory pressure to suck up body fluids (secretion in the respiratory tract) just like when people inhale. This product contains a regulator which can control the pressure and the flow so that the user can setup expiratory pressure, suction pressure, and flow. Also, this product contains Bacterial filter to prevent the inflow of body fluids into the body part of the product.

Seoil Pacific Corp.

Positive pressure airway secretion-clearing device

• Primary Device ID: 08809517011064
• NIH Device Record Key: dffac5b1-3a64-465f-925e-e15d04c0c354
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Cough
• Version Model Number: SICC2001
• Catalog Number: A10006
• Company DUNS: 694860085
• Company Name: Seoil Pacific Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr
• Phone: +8223252106
• Email: sungha@seoilpacific.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809517011064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113549

FDA Product Code

• NHJ: Device, Positive Pressure Breathing, Intermittent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-27
• Device Publish Date: 2025-02-19