EMI

GUDID 16946430414370

It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the counter-use.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Cardiopulmonary resuscitation mask, single-use
Primary Device ID16946430414370
NIH Device Record Keyf4dfe305-9638-4313-9ddc-6ec9a47cbd66
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMI
Version Model NumberCP646003
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106946430414373 [Primary]
GS116946430414370 [Package]
Contains: 06946430414373
Package: carton [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

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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