FDA.reportPublic FDA data

Trachealator Non-occlusive Airway Dilation Balloon

Primary DI
06009698453178
Brand
Trachealator Non-occlusive Airway Dilation Balloon
Company
DISA MEDINOTEC (PTY) LTD
Model
TRD1-16040
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTIBronchoscope Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211894000TrachealatorDisa Medinotec2021-11-24KTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009698453178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009698453178060096984531786009698453178

GMDN Terms#

Term, Definition table
TermDefinition
Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter16Millimeter

Regulatory Flags#

DUNS number
539157634
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonTRD1-145402026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonTRD1-180402026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonTRD1-070302026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonTRD1-080302026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonTRD1-090302026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonTRD1-100302026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonTRD1-120402026-05-20
06009698453789OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-180402026-05-20
06009698453796OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-200402026-05-20
06009698453802OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-230402026-05-20
06009698453819OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-250402026-05-20
06009698453826OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterOTF1-280402026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonTRD1-060302026-05-19
06009698450009TrachealatorTRD12023-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-19
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