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Comfort Cough

FDA UDIEUDAMED

Class II (US FDA UDI)

by Seoil Pacific Corp.

Identity

Trade Name
Comfort Cough FDA UDI
Generic Name
Positive pressure airway secretion-clearing device FDA UDI
Device Name
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. FDA UDI
Model / Reference
SICC2001 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
A10006 FDA UDI
Primary DI / UDI-DI
08809517011064 FDA UDI
510(k) Number
K113549 FDA UDI
FDA Product Code
NHJ FDA UDI
GMDN Term
Positive pressure airway secretion-clearing device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Positive pressure airway secretion-clearing device

Comfort Cough by Seoil Pacific Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Positive pressure airway secretion-clearing device.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Seoil Pacific Corp.

Sources (2)

  • FDA UDI dffac5b1-3a64-465f-925e-e15d04c0c354 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026