MTEHFYAF

Basic Information

• Brand Name: MTEHFYAF
• Primary DI: 06975029700078
• Version / Model: MY-QYJ-01
• Company Name: Beijing Xingjian Yongzhen Technology Co. , Ltd.
• Labeler DUNS: 414510435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-12
• Public Version: 1
• Public Version Date: 2024-06-20
• Public Version Status: New
• Public Device Record Key: eec46e66-0268-45d6-91ba-51eed5244b34

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: No
• 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
BYW	Device, Rebreathing	Anesthesiology	868.5675	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35171	Rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975029700078	GS1