FDA.reportPublic FDA data

NA

Primary DI
16938119326487
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Left:Fr28
Device description
The Endobronchial tube contians 1Pc Fr28 Left Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr8 Suction catheter, 1Pc Fr10 Suction catheter.
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K152251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152251000Endobronchial TubeHenan Tuoren Medical Device Co., Ltd.2016-06-10CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938119326487PackageGS110In Commercial Distribution
06938119326480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811932648716938119326487
06938119326480069381193264806938119326480

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526982680
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938119329429NABending edge:0#2022-11-18
06938119329450NABending edge:1#2022-11-18
06938119329481NABending edge:2#2022-11-18
06938119329511NABending edge:3#2022-11-18
06938119329542NABending edge:4#2022-11-18
06938119329573NABending edge:5#2022-11-18
06938119329603NA Detachable model:3#2022-11-18
06938119329634NA Detachable model:4#2022-11-18
06938119329665NA Detachable model:5#2022-11-18
06938119331071NAInfant2022-11-18
06938119331101NATracheotomy 2022-11-18
06938119359020NAMedical Laryngeal Mask Airway(Normal model:1.0# )2022-11-19
06938119359051NAMedical Laryngeal Mask Airway(Normal model:1.5# )2022-11-19
06938119359099NAMedical Laryngeal Mask Airway(Normal model:2.0# )2022-11-19
06938119359136NAMedical Laryngeal Mask Airway(Normal model:2.5# )2022-11-19
06938119359174NAMedical Laryngeal Mask Airway(Normal model:3.0# )2022-11-19
06938119359211NAMedical Laryngeal Mask Airway(Normal model:4.0# )2022-11-19
06938119359259NAMedical Laryngeal Mask Airway(Normal model:5.0# )2022-11-19
06938119359860NABlockbuster Laryngeal Mask Airway(model:1.0# )2022-11-19
06938119359907NABlockbuster Laryngeal Mask Airway(model:1.5# )2022-11-19

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