FDA.reportPublic FDA data

ANKOR endobronchial tube

Primary DI
08800115141979
Brand
ANKOR endobronchial tube
Company
INSUNG MEDICAL Co., Ltd..
Model
ABC37R
Published
2025-04-29
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
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
K200968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200968000ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd.2020-12-28CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800115141979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800115141979088001151419798800115141979

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial tubeA hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687938530
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800115141801Human-broncho endobronchial tubeHBC33L2025-04-29
08800115141818Human-broncho endobronchial tubeHBC33R2025-04-29
08800115141825Human-broncho endobronchial tubeHBC35L2025-04-29
08800115141832Human-broncho endobronchial tubeHBC35R2025-04-29
08800115141849Human-broncho endobronchial tubeHBC37L2025-04-29
08800115141856Human-broncho endobronchial tubeHBC37R2025-04-29
08800115141863Human-broncho endobronchial tubeHBC39L2025-04-29
08800115141870Human-broncho endobronchial tubeHBC39R2025-04-29
08800115141924ANKOR endobronchial tubeABC33L2025-04-29
08800115141931ANKOR endobronchial tubeABC33R2025-04-29
08800115141948ANKOR endobronchial tubeABC35L2025-04-29
08800115141955ANKOR endobronchial tubeABC35R2025-04-29
08800115141962ANKOR endobronchial tubeABC37L2025-04-29
08800115141986ANKOR endobronchial tubeABC39L2025-04-29
08800115141993ANKOR endobronchial tubeABC39R2025-04-29

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