HEADSTAR

Basic Information

• Brand Name: HEADSTAR
• Primary DI: 04711402233021
• Version / Model: HP-8609
• 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: 2020-03-26
• Public Version: 1
• Public Version Date: 2020-04-03
• Public Version Status: New
• Public Device Record Key: 54e8f74b-85c7-4ba5-8234-1545da8e9405

Device Description

VENTURI MASK KIT - CHILD CHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) Package: 50 PCS in CS

Device Characteristics

• Single Use: Yes
• 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 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
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	868.5600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35175	Venturi oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04711402233021	GS1