Chin strap

Basic Information

• Brand Name: Chin strap
• Primary DI: 00848530080983
• Version / Model: CS005PL
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-14
• Public Version: 1
• Public Version Date: 2024-06-24
• Public Version Status: New
• Public Device Record Key: f766b7a7-fe4b-4b7b-9829-1d4481b1cc48

Device Description

Comfort Chinstrap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
BTK	Strap, Head, Gas Mask	Anesthesiology	868.5560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65874	CPAP/BPAP chin strap, reusable	A non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal to adult patients. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530080983	GS1