EMI

GUDID 16946430414363

The cardiopulmonary resuscitation aid kit comprises of one CPR mask with 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 oxygen support (inhalation) or cardiopulmonary resuscitation (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.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

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Primary Device ID16946430414363
NIH Device Record Key4b0f3c38-c86d-42c4-a8b3-27c64a43c2e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMI
Version Model NumberCP641000+2A+PG
Company DUNS543482946
Company NameXIAMEN COMPOWER MEDICAL TECH. CO., LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946430414366 [Primary]
GS116946430414363 [Package]
Contains: 06946430414366
Package: carton [60 Units]
In Commercial Distribution

FDA Product Code

OEVCardiopulmonary Resuscitation Aid Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-23
Device Publish Date2022-11-15

On-Brand Devices [EMI]

16946430413656Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
16946430413649Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
16946430414370It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-sterile dev
16946430414363The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces

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