FDA.reportPublic FDA data

Bronchial endoscope

Primary DI
03700620600280
Brand
Bronchial endoscope
Company
EFER ENDOSCOPY
Model
BX-4000-SA
Device description
Autoclavable bronchial endoscope diameter 4 mm, 0° direction of view, compatible with BRONCHOSCOPE EFER-DUMON bronchial tubes and color coded red plunger tube
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854414000DUMON/HARRELLBryan Corp.1986-03-12EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700620600280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700620600280037006206002803700620600280

GMDN Terms#

Term, Definition table
TermDefinition
Rigid bronchoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
286097451
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049113104973Luer Rongeur forceps411-5482023-11-14
04250302227209Optical grasping forceps32-3230-430HM2023-11-14
04250302227216Optical stent removal forceps32-3230-430HM-SA2023-11-14
04250302227223Optical biopsy forceps32-3231RD-4-4302023-11-14
G006DJ40431621Sterilization basketDJ-40432023-11-14
G006DJ4046SPEC927Sterilzation basket with lidDJ-4046-SPEC2023-11-14
G006DJ4371178Sterilization basket with lidDJ-43712023-11-14
G006DJ45611715Sterilization basket without lidDJ-45612023-11-14
G006DJ4561SPEC1117Sterilization basket without lidDJ-4561-SPEC2023-11-14
G006DJ45861733Lid for sterilization basketDJ-48862023-11-14
G006DJ4586SPEC142Lid for sterilization basketDJ-4586-SPEC2023-11-14
G006DJ4928195Silicone matDJ-49282023-11-14
G006DJ4929197Silicone matDJ-49292023-11-14
03700620600006Endoscope connectorC42023-11-07
03700620600020Endoscope connectorC12023-11-07
03700620600037Silicone capBS2319-32023-11-07
03700620600044Silicone capBS2318-32023-11-07
03700620600051Silicone capBS2317-32023-11-07
03700620600068Silicone capBS2316-32023-11-07
03700620600082Silicone capBS2314-32023-11-07

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