Flexible Video Laryngoscope (NTSC) 02-5201

GUDID 00874485000868

COGENTIX MEDICAL, INC.

Flexible video laryngoscope
Primary Device ID00874485000868
NIH Device Record Keyf31de730-326e-4162-8d7f-cd5837306c9e
Commercial Distribution Discontinuation2018-07-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFlexible Video Laryngoscope (NTSC)
Version Model NumberENT-5000
Catalog Number02-5201
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
GS100874485000868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00874485000868]

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

On-Brand Devices [Flexible Video Laryngoscope (NTSC)]

00874485002671ENT-7000
00874485000868ENT-5000

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