Emergency Rescue Mask

GUDID B859ERM1010

It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

CBX LLC

Cardiopulmonary resuscitation mask, single-use
Primary Device IDB859ERM1010
NIH Device Record Key67b4cc64-3e03-4c5d-b864-5e7787fcc1d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmergency Rescue Mask
Version Model NumberERM101
Company DUNS110960383
Company NameCBX LLC
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB859ERM1010 [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 Date2020-02-24
Device Publish Date2020-02-15

Devices Manufactured by CBX LLC

B859FRK1021 - First Responder Kit2021-04-09 First Responder Kit contains CPR mask, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and N
B859FRK10109 - First Responder Kit2020-03-27 First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile gloves, emergency shears, safety prep razor, dry cle
B859ERM1010 - Emergency Rescue Mask2020-02-24It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.
B859ERM1010 - Emergency Rescue Mask2020-02-24 It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

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