FDA.reportPublic FDA data

SILBRONCHO (LEFT LUNG)

Primary DI
14544050123942
Brand
SILBRONCHO (LEFT LUNG)
Company
FUJI SYSTEMS CORPORATION
Model
#35
Catalog number
1203535
Device description
SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K051522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051522000SILBRONCHO DOUBLE LUMEN TUBEFuji Systems Corp.2005-08-17CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14544050123942PackageGS11In Commercial Distribution
04544050061186PreviousGS10
04544050123945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454405012394214544050123942
04544050061186045440500611864544050061186
04544050123945045440501239454544050123945

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
715919973
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
04544050121057CELLO II Balloon Guide Catheter, 8F 90cm16509082026-05-25
04544050123815UNIVENT TUBE (TCB TYPE)I.D. 8.0MM12029332024-01-31
04544050123839UNIVENT TUBE (TCB TYPE)I.D. 6.0MM12029272024-01-31
04544050123846UNIVENT TUBE (TCB TYPE)I.D. 6.5MM12029282024-01-31
04544050123853UNIVENT TUBE (TCB TYPE)I.D. 7.0MM12029302024-01-31
04544050123860UNIVENT TUBE (TCB TYPE)I.D. 7.5MM12029312024-01-31
04544050123877UNIVENT TUBE (TCB TYPE)I.D. 8.5MM12029352024-01-31
04544050123884UNIVENT TUBE (TCB TYPE)I.D. 9.0MM12029362024-01-31
04544050123891UNIVENT TUBE (TCB TYPE)I.D. 9.5MM12029372024-01-31
04544050123907UNIVENT TUBE (TCB TYPE)I.D. 10.0MM12029392024-01-31
14544050123812UNIVENT TUBE (TCB TYPE)I.D. 8.0MM12029332024-01-31
14544050123836UNIVENT TUBE (TCB TYPE)I.D. 6.0MM12029272024-01-31
14544050123843UNIVENT TUBE (TCB TYPE)I.D. 6.5MM12029282024-01-31
14544050123850UNIVENT TUBE (TCB TYPE)I.D. 7.0MM12029302024-01-31
14544050123867UNIVENT TUBE (TCB TYPE)I.D. 7.5MM12029312024-01-31
14544050123874UNIVENT TUBE (TCB TYPE)I.D. 8.5MM12029352024-01-31
14544050123881UNIVENT TUBE (TCB TYPE)I.D. 9.0MM12029362024-01-31
14544050123898UNIVENT TUBE (TCB TYPE)I.D. 9.5MM12029372024-01-31
14544050123904UNIVENT TUBE (TCB TYPE)I.D. 10.0MM12029392024-01-31
04544050120739CELLO™, Balloon Guide Catheter16105802022-01-18

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