Portable LED Light Source 07-3050

GUDID 00874485000318

COGENTIX MEDICAL, INC.

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• Primary Device ID: 00874485000318
• NIH Device Record Key: 1ecef7bc-dc0e-4405-bc53-0f7b639ae190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable LED Light Source
• Version Model Number: BLS-1000
• Catalog Number: 07-3050
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100125

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

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