FDA.reportPublic FDA data

Insighters

Primary DI
06970831723673
Brand
Insighters
Company
Shenzhen Insighters Medical Technology Co., Ltd.
Model
Visible Left type 35Fr
Published
2026-04-14
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
K232529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232529000Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.2024-05-13CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970831723673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970831723673069708317236736970831723673

GMDN Terms#

Term, Definition table
TermDefinition
Tracheobronchial suction/insufflation catheter, dual-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a dual-lumen tube which allows simultaneous suction and insufflation. 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
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
06970831723857InsightersVisible Right type B 35Fr2026-04-14

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
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
06970831723369InsightersShenzhen Insighters Medical Technology Co., Ltd.CBI2026-04-10
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
14026704941152SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
14026704941169SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11
14026704941176SHERIDANTELEFLEX INCORPORATEDCBI2025-12-11