ema-FH

GUDID 00860005753024

ema-Fixed Hinge

SERENA SLEEP SOLUTIONS LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00860005753024
• NIH Device Record Key: e6b26da7-4701-4e4d-af46-e53b5371d208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ema-FH
• Version Model Number: ema-FH
• Company DUNS: 121617550
• Company Name: SERENA SLEEP SOLUTIONS LLC
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005753024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203606

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

Devices Manufactured by SERENA SLEEP SOLUTIONS LLC

• 00860005753000 - Elevate: 2024-06-13 Step Mandibular Advancement
• 00860005753024 - ema-FH: 2024-06-13ema-Fixed Hinge
• 00860005753024 - ema-FH: 2024-06-13 ema-Fixed Hinge
• 00860005753048 - Flex: 2024-06-13 Step Mandibular Advancement (BMA)
• 00860005753055 - Serena Nylon ema: 2024-06-13 ema sleep apnea appliances
• 00860005753062 - Versa: 2024-06-13 Step Mandibular Advancement
• 00860005753079 - Versa ema: 2024-06-13 Nylon ema
• 00860005753086 - Nylon Nightguard/Occlusal Appliance: 2024-06-13 Nylon Nightguard/Occlusal Appliance