Rescue Breather CPR Protective barrier 01RB2020-R

GUDID 17540195055060

The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. Each Rescue Breather is packed with a pair of gloves in a Red nylon keychain/belt pouch.

O-Two Medical Technologies Inc

Face splash shield, single-use
Primary Device ID17540195055060
NIH Device Record Keyfec694bb-acfb-4fbf-b7cd-434f9e09a98e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRescue Breather CPR Protective barrier
Version Model Number01RB2020-Red-U
Catalog Number01RB2020-R
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195055063 [Primary]
GS117540195055060 [Package]
Contains: 07540195055063
Package: Packaging carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYMDevice, Cpr Assist

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 Date2016-09-23

On-Brand Devices [Rescue Breather CPR Protective barrier]

17540195055077The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
17540195055060The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
07540195055056The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
17540195055046The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
07540195055032The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
07540195055025The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's

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