Blue + Hard

Basic Information

• Brand Name: Blue + Hard
• Primary DI: 00851861007093
• Version / Model: SBP000US
• Company Name: RESPIRE MEDICAL HOLDINGS LLC
• Labeler DUNS: 059636679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-15
• Public Version: 5
• Public Version Date: 2020-02-17
• Public Version Status: Update
• Public Device Record Key: 0e5076a2-393f-408d-995d-774bc48454a8

Device Description

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851861007093	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111207	000

Device Sizes

Type	Value	Unit	Text
Circumference	200	Millimeter