FDA.reportPublic FDA data

UNIBLOCKER

Primary DI
04544050123914
Brand
UNIBLOCKER
Company
FUJI SYSTEMS CORPORATION
Model
5.0FR
Catalog number
1203104
Device description
UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lungresection, VATS, lobectomy, etc.
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K894337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894337000UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MMVitaid, Ltd.1989-09-29CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14544050123911PackageGS11In Commercial Distribution
04544050080965PreviousGS10
04544050123914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454405012391114544050123911
04544050080965045440500809654544050080965
04544050123914045440501239144544050123914

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
715919973
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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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