Narval CC 200046

GUDID 00619498020027

Connecting Rods Pack - Lower Range

RESMED MOTOR TECHNOLOGIES INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00619498020027
• NIH Device Record Key: d8b2f441-e707-46af-aecf-7e25a6e5cbe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Narval CC
• Version Model Number: 200046
• Catalog Number: 200046
• 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: true
• 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

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	00619498020027 [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