AccessGUDID - DEVICE: Respire Pink+ Hard with DentiTrac (00851861007222)

GUDID

Device Identifier (DI) Information

Brand Name: Respire Pink+ Hard with DentiTrac
Version or Model: SPPD000US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RESPIRE MEDICAL HOLDINGS LLC

Primary DI Number: 00851861007222
Issuing Agency: GS1
Commercial Distribution End Date: May 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 059636679 *Terms of Use

Device Description: Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
PLC	Sleep Appliances With Patient Monitoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170692	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
Circumference: 200 Millimeter

Device Record Status

Public Device Record Key: 91ecdf98-bb95-4540-aafa-54b4632f371f
Public Version Date: February 17, 2020
Public Version Number: 6
DI Record Publish Date: September 15, 2017