FDA.reportPublic FDA data

CipherOx CRI

Primary DI
00860003025604
Brand
CipherOx CRI
Company
FLASHBACK TECHNOLOGIES, INC.
Model
CRI
Device description
The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPWAdjunctive Cardiovascular Status Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPWAdjunctive Cardiovascular Status IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160020000CipherOx CRI TabletFlashback Technologies, Inc.2016-12-21PPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003025604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003025604008600030256048600030256040860003025604

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
415.624.5663kiernan.mcguire@flashbacktechnologies.com

Regulatory Flags#

DUNS number
968046099
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003025611Compensatory Reserve Tablet T1 V2020.04.22Compensatory Reserve Tablet T1 V2020.04.222020-05-19
00860003025628Compensatory Reserve Tablet T1 V2021.03.01Compensatory Reserve Tablet T1 V2020.04.222021-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071330144prolaio eVO2peak ModuleProlaio, Inc.PPW2026-05-07
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PPW2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PPW2026-03-17
00860003025628Compensatory Reserve Tablet T1 V2021.03.01FLASHBACK TECHNOLOGIES, INC.PPW2021-04-12
00860003025611Compensatory Reserve Tablet T1 V2020.04.22FLASHBACK TECHNOLOGIES, INC.PPW2020-05-19
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PPW2016-09-09