SnoreLogic

GUDID 15035883000917

PASSION FOR LIFE HEALTHCARE (UK) LIMITED

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 15035883000917
• NIH Device Record Key: a326abb8-b788-45e6-b49c-9e4956f5579a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnoreLogic
• Version Model Number: SMAN-USA-001-V1
• Company DUNS: 211652915
• Company Name: PASSION FOR LIFE HEALTHCARE (UK) LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com
• Phone: 17632007808
• Email: llc@passionforlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15035883000917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181396

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: 2
• Public Version Date: 2023-12-25
• Device Publish Date: 2023-01-16