HEADSTAR

Basic Information

• Brand Name: HEADSTAR
• Primary DI: 04711402233052
• Version / Model: HP-8508
• Company Name: HEADSTAR MEDICAL PRODUCTS CO., LTD.
• Labeler DUNS: 658122049
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-25
• Public Version: 1
• Public Version Date: 2021-04-02
• Public Version Status: New
• Public Device Record Key: 685fa00f-d0bc-42e8-bbb8-404c48784095

Device Description

Headstar Tracheotomy mask comes in adult sizes and is designed to deliver oxygen and humidity to Tracheotomy patient. HP-8508 Adult Tracheotomy Mask (connector ID: 18mm / OD:22mm)

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: Yes
• MRI Safety: MR Safe
• 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
BYG	Mask, Oxygen	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35178	Tracheostomy mask, oxygen	A device designed to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04711402233052	GS1