AccessGUDID - DEVICE: ShuntCheck III Software (00865435000311)

GUDID

Device Identifier (DI) Information

Brand Name: ShuntCheck III Software
Version or Model: SCIII SW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCIII SW
Company Name: NEURODX DEVELOPMENT LLC

Primary DI Number: 00865435000311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828682240 *Terms of Use

Device Description: ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph

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?
60309	Heater/cooler system tester kit	A collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The kit may include a pressure/flow calibration unit, a thermocouple thermometer, a breakout box and relevant connection cables. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, Central Nervous System And Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123554	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: d7a175c0-f51f-41ef-bfc7-c8dd9fd38458
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 18, 2018