Flexible Fiber Laryngoscope, Standard Set Recondit 02-4202P

GUDID 00874485002955

Reconditioned

COGENTIX MEDICAL, INC.

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 00874485002955
• NIH Device Record Key: 1117cc78-01e3-4144-87c6-d1cccfb5724d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Fiber Laryngoscope, Standard Set Recondit
• Version Model Number: ENT-4000
• Catalog Number: 02-4202P
• 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: false
• 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.c

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485002955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050972

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

[00874485002955]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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
• 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