CipherOx CRI

Basic Information

• Brand Name: CipherOx CRI
• Primary DI: 00860003025604
• Version / Model: CRI
• Company Name: FLASHBACK TECHNOLOGIES, INC.
• Labeler DUNS: 968046099
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 6ea42b43-47a4-4d0f-a8ea-0f9e87506ac2

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPW	Adjunctive Cardiovascular Status Indicator	Cardiovascular	870.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31658	Pulse oximeter probe, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003025604	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN160020	000