AccessGUDID - DEVICE: Ever One (06946430401205)

GUDID

Device Identifier (DI) Information

Brand Name: Ever One
Version or Model: CP641002+2A+PG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Primary DI Number: 06946430401205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543482946 *Terms of Use

Device Description: The cardiopulmonary resuscitation aid kit comprises of one CPR mask without Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1b195cd-6f13-4f81-a6b4-5ba0cea6870a
Public Version Date: November 23, 2018
Public Version Number: 1
DI Record Publish Date: October 23, 2018