compower

Basic Information

• Brand Name: compower
• Primary DI: 06946430400482
• Version / Model: CP641007+2A+NG
• 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: 2018-02-28
• Public Version: 2
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: e94feb0d-c7cf-4e4b-a1b4-e32d59a1fb31

Device Description

Cardiopulmonary resuscitation kit contains Infant CPR Mask without Oxygen Port, two pieces alcohol pads and one pair Nitril glove. 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16946430400489	GS1	carton	50	In Commercial Distribution
Primary	06946430400482	GS1