FDA.reportPublic FDA data

EndoSheath Technology

Primary DI
00874485003050
Brand
EndoSheath Technology
Company
COGENTIX MEDICAL, INC.
Model
BF-0
Catalog number
04-4105
Device description
EndoSheath Technology for BRS-4000 Fiber Bronchoscope
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
K091768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091768000VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIESVision-Sciences, Inc.2009-08-03EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20874485001562PackageGS110In Commercial Distribution
00874485003050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087448500156220874485001562
00874485003050008744850030508744850030500874485003050

GMDN Terms#

Term, Definition table
TermDefinition
Optical medical device procedural coverA device designed to fit over the distal end of a hand-held, non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use to act as a cover/shield to avoid cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid plastic device which includes a transparent window. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
780024725
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00874485000844Flexible Video Esophagoscope (NTSC)TNE-500003-52012016-09-22
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
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
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04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
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04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
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10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
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