FDA.reportPublic FDA data

Flexible Video Esophagoscope (NTSC)

Primary DI
00874485000844
Brand
Flexible Video Esophagoscope (NTSC)
Company
COGENTIX MEDICAL, INC.
Model
TNE-5000
Catalog number
03-5201
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOXEsophagoscope (Flexible Or Rigid)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072088000FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMSVision-Sciences, Inc.2007-08-29EOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874485000844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874485000844008744850008448744850008440874485000844

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, reusableAn endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
866-258-2182customercare@cogentixmedical.com

Regulatory Flags#

DUNS number
780024725
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00874485003180Endoscopic Cytology Brush07-90012016-09-23
00874485003197Nasal Cytology Brush07-90062016-09-23
00874485002367Flexible Video Bronchoscope (NTSC)BRS-510004-52032016-09-22
00874485002848Flexible Video Bronchoscope (NTSC) ReconditionedBRS-510004-5203P2016-09-22
00874485002879Flexible Video Esophagoscope (NTSC) ReconditionedTNE-500003-5201P2016-09-22
00874485000318Portable LED Light SourceBLS-100007-30502016-09-23
00874485002985EndoSheath TechnologyTV-2.103-51012016-09-23
00874485003005EndoSheath TechnologyTV-1.503-51022016-09-23
00874485003029EndoSheath TechnologyBF-2.104-41012016-09-23
00874485003036EndoSheath TechnologyBF-1.504-41022016-09-23
00874485003043EndoSheath TechnologyBF-2.804-41032016-09-23
00874485003050EndoSheath TechnologyBF-004-41052016-09-23
00874485003067EndoSheath TechnologyBV-2.104-51012016-09-23
00874485003074EndoSheath TechnologyBV-1.504-51022016-09-23
00874485003098EndoSheath TechnologyBV-004-51052016-09-23
00874485003104EndoSheath TechnologyBVX-2.104-51112016-09-23
00874485003111EndoSheath TechnologyBVX-1.504-51122016-09-23
00874485003128EndoSheath TechnologyBVX-2.804-51132016-09-23
00874485003135EndoSheath TechnologyBVX-004-51152016-09-23
00874485003142EndoSheath TechnologyCF-2.108-41012016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333251766PENTAX MedicalHOYA CORPORATIONEOX2023-06-21
00860008795557EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2023-01-26
04048551417348n.a.Karl Storz GmbH & Co. KGEOX2020-03-02
00860002356006EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2019-12-17
00874485003210UNITY 9100COGENTIX MEDICAL, INC.EOX2018-12-20
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
00874485002985EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
00874485003005EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
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