Narval CC 200002

GUDID 00619498020041

Mandibular Repositioning Device

RESMED MOTOR TECHNOLOGIES INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00619498020041
• NIH Device Record Key: 6668120e-5354-4e34-b2cc-390cd601a956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Narval CC
• Version Model Number: 200002
• Catalog Number: 200002
• Company DUNS: 147450258
• Company Name: RESMED MOTOR TECHNOLOGIES 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: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498020041 [Primary]

FDA Product Code

• LQZ: Device, Jaw Repositioning

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: 2018-03-29
• Device Publish Date: 2016-09-05

On-Brand Devices [Narval CC]

• 00619498020041: Mandibular Repositioning Device
• 00619498020034: Connecting Rods Pack - Upper range
• 00619498020027: Connecting Rods Pack - Lower Range