Flexible Video Bronchoscope (NTSC) 04-5203

GUDID 00874485002367

COGENTIX MEDICAL, INC.

Flexible video bronchoscope, reusable
Primary Device ID00874485002367
NIH Device Record Keyd4420fb7-97b5-44b3-bac8-0c99a6e2248e
Commercial Distribution Discontinuation2018-07-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFlexible Video Bronchoscope (NTSC)
Version Model NumberBRS-5100
Catalog Number04-5203
Company DUNS780024725
Company NameCOGENTIX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-258-2182
Emailcustomercare@cogentixmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100874485002367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00874485002367]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-02
Device Publish Date2016-09-22

Devices Manufactured by COGENTIX MEDICAL, INC.

00874485002954 - Flexible Fiber Laryngoscope, Standard Set Reconditioned2019-07-02 Reconditioned
00874485000844 - Flexible Video Esophagoscope (NTSC)2019-07-02
00874485000868 - Flexible Video Laryngoscope (NTSC)2019-07-02
00874485000943 - Video Processor2019-07-02 Digital Processing Unit with Integrated LCD Display and Air Insufflation
00874485001360 - Flexible Fiber Laryngoscope, Standard Set2019-07-02
00874485001544 - Flexible Fiber Bronchoscope2019-07-02
00874485001629 - Flexible Fiber Laryngoscope, Standard Set2019-07-02
00874485002367 - Flexible Video Bronchoscope (NTSC)2019-07-02
00874485002367 - Flexible Video Bronchoscope (NTSC)2019-07-02

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