AccessGUDID - DEVICE: Xltek (00382830043441)

GUDID

Device Identifier (DI) Information

Brand Name: Xltek
Version or Model: 012001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Embla Systems Ltd

Primary DI Number: 00382830043441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203408612 *Terms of Use

Device Description: RemLogic 3.3.2 Installation CD ENU

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polysomnography device application software	An individual software application program, routines or algorithms designed for use in, or together with, a polysomnography device so that this may function according to its intended purpose. A basic set of applications programs and routines are included with the sleep assessment device and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software can be installed in the device and/or a computer workstation (e.g., an off-the-shelf desktop or laptop).

GMDN Preferred Term Name

GMDN Definition

Polysomnography device application software

An individual software application program, routines or algorithms designed for use in, or together with, a polysomnography device so that this may function according to its intended purpose. A basic set of applications programs and routines are included with the sleep assessment device and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software can be installed in the device and/or a computer workstation (e.g., an off-the-shelf desktop or laptop).

FDA Product Code

[?]

Product Code	Product Code Name
OLV	Standard Polysomnograph With Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 40a0f72d-bdf6-4800-a27b-196942c692d5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 25, 2016