Headgear

Basic Information

• Brand Name: Headgear
• Primary DI: 06922166511517
• Version / Model: H5
• Company Name: Suzhou Yuyue Medical Technology Co., Ltd.
• Labeler DUNS: 421307196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-14
• Public Version: 1
• Public Version Date: 2023-11-22
• Public Version Status: New
• Public Device Record Key: 6d16a98a-94dc-44e2-a680-aa8152a959db

Device Description

Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YP-01)

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: Yes
• 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
41067	Orthodontic chin cap/cup	A dental device component of an extraoral orthodontic headgear designed to help reduce/correct mandibular prognathism by applying reverse pull force to the chin, via tight attachment to the headgear head straps. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26922166511511	GS1	Carton	20	In Commercial Distribution
Primary	06922166511517	GS1