Flexible Video Esophagoscope (NTSC) 03-5201

GUDID 00874485000844

COGENTIX MEDICAL, INC.

Flexible video bronchoscope, reusable

• Primary Device ID: 00874485000844
• NIH Device Record Key: 0cfe24d9-3017-4be2-b8b2-6871adce2e0d
• Commercial Distribution Discontinuation: 2018-07-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Flexible Video Esophagoscope (NTSC)
• Version Model Number: TNE-5000
• Catalog Number: 03-5201
• Company DUNS: 780024725
• Company Name: COGENTIX MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-258-2182
• Email: customercare@cogentixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485000844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072088

FDA Product Code

• EOX: Esophagoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00874485000844]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-02
• Device Publish Date: 2016-09-22

Devices Manufactured by COGENTIX MEDICAL, INC.

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