Fusion Flex

GUDID 00851826007045

Oral Device For The Treatment Of Obstructive Sleep Apnea.

SOMNOMED, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851826007045
• NIH Device Record Key: f56d37ff-ab4a-4cc4-8d20-e05585064a9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Flex
• Version Model Number: L7001
• Company DUNS: 623527962
• Company Name: SOMNOMED, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-447-6673
• Email: customerservice@somnomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851826007045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140278

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

Devices Manufactured by SOMNOMED, INC.

• 00851826007281 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT with Strap Kit A
• 00851826007298 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT with Strap Kit B
• 00851826007304 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT with Strap Kit C
• 00851826007311 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT Strap Kit A
• 00851826007328 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT Strap Kit B
• 00851826007335 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT Strap Kit C
• 00851826007342 - SomnoDent AVANT: 2024-08-22 SomnoDent AVANT Strap Kit D
• 00851826007199 - SomnoDent AVANT: 2019-09-06 SomnoDent Avant kit with Large Strap Set