EMI

GUDID 16946430413649

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Pulmonary resuscitator, manual, single-use
Primary Device ID16946430413649
NIH Device Record Key4381f392-acd0-4896-9713-f00a3e873203
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMI
Version Model NumberNPVC-001/RTMA
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
GS106946430413642 [Primary]
GS116946430413649 [Package]
Contains: 06946430413642
Package: carton [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-28
Device Publish Date2022-03-19

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.