WNL product

Basic Information

• Brand Name: WNL product
• Primary DI: 06946430410399
• Version / Model: CP641007
• Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD
• Labeler DUNS: 543482946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-29
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 9412df63-2b5b-490a-8470-bf248dfb9787

Device Description

Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61326	Cardiopulmonary resuscitation mask, single-use	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16946430410396	GS1	carton	100	In Commercial Distribution
Primary	06946430410399	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171961	000