FDA.reportPublic FDA data

MultiStage®

Primary DI
06934184007224
Brand
MultiStage®
Company
Dongguan TT Medical, Inc.
Model
MSW-1030-09
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K222187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222187000Multistage Balloon Dilatation CatheterDongguan TT Medical, Inc.2023-03-01KTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934184007224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934184007224069341840072246934184007224

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551476865
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934184004100MultiStage®MSO-0630-082025-02-10
06934184004117MultiStage®MSW-0830-082025-02-10
06934184004124MultiStage®MSO-1030-082025-02-10
06934184004131MultiStage®MSO-1230-082025-02-10
06934184004148MultiStage®MSO-1530-082025-02-10
06934184004155MultiStage®MSO-1830-082025-02-10
06934184004162MultiStage®MSO-0630-172025-02-10
06934184004179MultiStage®MSO-0830-172025-02-10
06934184004186MultiStage®MSO-1030-172025-02-10
06934184004193MultiStage®MSO-1230-172025-02-10
06934184004209MultiStage®MSO-1530-172025-02-10
06934184004216MultiStage®MSO-1830-172025-02-10
06934184004223MultiStage®MSO-0630-232025-02-10
06934184004230MultiStage®MSO-0830-232025-02-10
06934184004254MultiStage®MSO-1230-232025-02-10
06934184004261MultiStage®MSO-1530-232025-02-10
06934184004278MultiStage®MSO-1830-232025-02-10
06934184004285MultiStage®MSO-0655-082025-02-10
06934184004292MultiStage®MSO-0855-082025-02-10
06934184004308MultiStage®MSO-1055-082025-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06009698453178Trachealator 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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00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00816734023518BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
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00850081350019Monarch Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350026Monarch Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350033Olympus Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350040Olympus Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00860003935842EndoCorePRAXIS MEDICAL LLCKTI2025-11-06
00860003935859Ion Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
04953170458378Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458385Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458392Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458408Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458375Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458382Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458399Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458405Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14