AccessGUDID - DEVICE: NARVAL CC (03760287780022)

GUDID

Device Identifier (DI) Information

Brand Name: NARVAL CC
Version or Model: 200002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RESMED SA

Primary DI Number: 03760287780022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 383473204 *Terms of Use

Device Description: The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient's pharyngeal space, improving their ability to exchange air and reducing their tendency to snore.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQZ	Device, Jaw Repositioning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113201	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea2dec3c-48ae-4f44-a18e-26faa5439ba1
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 18, 2018