AccessGUDID - DEVICE: Retia Medical (00860001506402)

GUDID

Device Identifier (DI) Information

Brand Name: Retia Medical
Version or Model: FG-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RETIA MEDICAL, LLC

Primary DI Number: 00860001506402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025675871 *Terms of Use

Device Description: The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.

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?
61237	Noninvasive haemodynamic monitoring system	An assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181372	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: 8784c849-5516-451d-88f2-661f3157bb27
Public Version Date: April 29, 2019
Public Version Number: 1
DI Record Publish Date: April 19, 2019