PureSleep PSKITA2ES

GUDID 00851727004020

One PureSleep Anti-Snoring Mouthpiece Kit US

SLEEP SCIENCE PARTNERS, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851727004020
• NIH Device Record Key: 6175c041-8234-42cd-8fb2-6f55f8f8f9b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureSleep
• Version Model Number: PSKITA2ES
• Catalog Number: PSKITA2ES
• Company DUNS: 808128693
• Company Name: SLEEP SCIENCE PARTNERS, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851727004020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954128

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: 2018-08-27
• Device Publish Date: 2018-07-27

Devices Manufactured by SLEEP SCIENCE PARTNERS, INC.

• 00851727004037 - PureSleep Pro: 2018-08-30 One PureSleep PRO Anti-Snoring Device Kit US
• 00851727004020 - PureSleep: 2018-08-27One PureSleep Anti-Snoring Mouthpiece Kit US
• 00851727004020 - PureSleep: 2018-08-27 One PureSleep Anti-Snoring Mouthpiece Kit US