AccessGUDID - DEVICE: CipherOx CRI (00860003025604)

GUDID

Device Identifier (DI) Information

Brand Name: CipherOx CRI
Version or Model: CRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLASHBACK TECHNOLOGIES, INC.

Primary DI Number: 00860003025604
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968046099 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPW	Adjunctive Cardiovascular Status Indicator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160020	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ea42b43-47a4-4d0f-a8ea-0f9e87506ac2
Public Version Date: November 10, 2021
Public Version Number: 2
DI Record Publish Date: May 19, 2020