FDA.reportPublic FDA data

Insighters

Primary DI
06970831723369
Brand
Insighters
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
5Fr
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232580000Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.2023-12-14CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970831723369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970831723369069708317233696970831723369

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.

Regulatory Flags#

DUNS number
551096917
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
06970831723659InsightersVisible Left type 28Fr2026-04-14
06970831723666InsightersVisible Left type 32Fr2026-04-14
06970831723673InsightersVisible Left type 35Fr2026-04-14
06970831723680InsightersVisible Left type 37Fr2026-04-14
06970831723697InsightersVisible Left type 39Fr2026-04-14
06970831723703InsightersVisible Left type 41Fr2026-04-14
06970831723710InsightersVisible Right type 28Fr2026-04-14
06970831723727InsightersVisible Right type 32Fr2026-04-14
06970831723734InsightersVisible Right type 35Fr2026-04-14
06970831723741InsightersVisible Right type 37Fr2026-04-14
06970831723758InsightersVisible Right type 39Fr2026-04-14
06970831723765InsightersVisible Right type 41Fr2026-04-14
06970831723772InsightersVisible Left type B 28Fr2026-04-14
06970831723789InsightersVisible Left type B 32Fr2026-04-14
06970831723796InsightersVisible Left type B 35Fr2026-04-14
06970831723802InsightersVisible Left type B 37Fr2026-04-14
06970831723819InsightersVisible Left type B 39Fr2026-04-14
06970831723826InsightersVisible Left type B 41Fr2026-04-14
06970831723833InsightersVisible Right type B 28Fr2026-04-14
06970831723840InsightersVisible Right type B 32Fr2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970831723659InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723666InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723673InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723680InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723697InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723703InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723710InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723727InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723734InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723741InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723758InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723765InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723772InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-14
06970831723376InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723383InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723536InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723543InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723550InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723567InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723574InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723581InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723598InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723604InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723611InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723628InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723635InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
06970831723642InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
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14026704941169SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
14026704941176SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11