AccessGUDID - DEVICE: DataLITE Management Software (Version 10) (05060481690850)

GUDID

Device Identifier (DI) Information

Brand Name: DataLITE Management Software (Version 10)
Version or Model: 510xx-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMETRICS LIMITED

Primary DI Number: 05060481690850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 519969810 *Terms of Use

Device Description: The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese.

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?
44813	Bio-energy mapping system application software	An individual software program or group of programs, routines and/or algorithms, that add specific image processing and/or analysis capabilities to a computer for storing, processing, managing and displaying electronic information/data used to interpret and map bio-energy parameters. It is typically for installation in an off-the-shelf desktop or laptop computer. Data from the impulses picked up by the sensor devices are processed by the software and assimilated with a knowledge management infrastructure that assists in producing the on-screen data and analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQX	Goniometer, Ac-Powered
IKK	System, Isokinetic Testing And Evaluation
HCC	Device, Biofeedback

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: a0ce0938-495b-4edc-a3de-3031435e151a
Public Version Date: September 10, 2018
Public Version Number: 1
DI Record Publish Date: August 10, 2018