SleepWeaver Elan - Mask & Headgear Starter Kit - B 100563

GUDID B036100563

SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large Cushions - Beige

CIRCADIANCE, LLC

CPAP/BPAP nasal mask, reusable

• Primary Device ID: B036100563
• NIH Device Record Key: 5ff5fb80-5e30-4210-ab6f-13e42f73a3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepWeaver Elan - Mask & Headgear Starter Kit - B
• Version Model Number: 100563
• Catalog Number: 100563
• Company DUNS: 012721295
• Company Name: CIRCADIANCE, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-825-9640
• Email: info@circadiance.com
• Phone: 1-888-825-9640
• Email: info@circadiance.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B036100563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120757

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2016-09-22

On-Brand Devices [SleepWeaver Elan - Mask & Headgear Starter Kit - B]

• B036100782: SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large Cushions - Blue
• B036100563: SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large Cushions - Beig