FDA.reportPublic FDA data

Comfort Cough

Primary DI
08809517011064
Brand
Comfort Cough
Company
Seoil Pacific Corp.
Model
SICC2001
Catalog number
A10006
Device 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.
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHJDevice, Positive Pressure Breathing, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113549000COMFORT COUGHSeoil Pacific Corp.2013-02-21NHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809517011064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809517011064088095170110648809517011064

GMDN Terms#

Term, Definition table
TermDefinition
Positive pressure airway secretion-clearing deviceA hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8223252106sungha@seoilpacific.co.kr

Regulatory Flags#

DUNS number
694860085
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-08-06
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08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2024-04-01
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00887761981690Volara SystemHILL-ROM SERVICES PTE. LTD.NHJ2023-11-28
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