CipherOx CRI

GUDID 00860003025604

The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.

FLASHBACK TECHNOLOGIES, INC.

Pulse oximeter probe, single-use
Primary Device ID00860003025604
NIH Device Record Key6ea42b43-47a4-4d0f-a8ea-0f9e87506ac2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCipherOx CRI
Version Model NumberCRI
Company DUNS968046099
Company NameFLASHBACK 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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com
Phone415.624.5663
Emailkiernan.mcguire@flashbacktechnologies.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003025604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPWAdjunctive Cardiovascular Status Indicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-10
Device Publish Date2020-05-19

Devices Manufactured by FLASHBACK TECHNOLOGIES, INC.

00860003025604 - CipherOx CRI2021-11-10The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
00860003025604 - CipherOx CRI2021-11-10 The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
00860003025611 - Compensatory Reserve Tablet T1 V2020.04.222021-11-10
00860003025628 - Compensatory Reserve Tablet T1 V2021.03.012021-04-20

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