AccessGUDID - DEVICE: Infinity PiCCO SmartPod Set (04049098005074)

GUDID

Device Identifier (DI) Information

Brand Name: Infinity PiCCO SmartPod Set
Version or Model: MS16734
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRAEGER MEDICAL SYSTEMS, INC.

Primary DI Number: 04049098005074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788289952 *Terms of Use

Device Description: No description.

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):	No
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?
36561	Patient monitoring system module, cardiac output	A small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.	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 [?]
K073113	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: 9f3b9645-cebf-4421-af89-1825c9ec7907
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015