CPR Bio-Barrier Training Faceshield 01RB5050

GUDID 17540195056029

CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission.

O-Two Medical Technologies Inc

Face splash shield, single-use
Primary Device ID17540195056029
NIH Device Record Key398457ff-783e-4138-8e82-d571028eff78
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPR Bio-Barrier Training Faceshield
Version Model Number01RB5050U
Catalog Number01RB5050
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
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
GS107540195056008 [Primary]
GS117540195056029 [Package]
Contains: 07540195056008
Package: Dispenser pouch [200 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2016-02-03

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