CPR Shield w/one way valve

GUDID 00616784492131

DYNAREX CORPORATION

Cardiopulmonary resuscitation mask, single-use
Primary Device ID00616784492131
NIH Device Record Key221d31c9-be7a-4a9a-a7f6-b391d0422410
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPR Shield w/one way valve
Version Model Number4921
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count100
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784492117 [Unit of Use]
GS100616784492131 [Primary]

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 Date2018-09-18
Device Publish Date2018-08-18

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