AccessGUDID - DEVICE: DataLOG MWX8 (05060481691789)

GUDID

Device Identifier (DI) Information

Brand Name: DataLOG MWX8
Version or Model: MWX8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MWX8 DataLOG - metal connectors
Company Name: BIOMETRICS LIMITED

Primary DI Number: 05060481691789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 519969810 *Terms of Use

Device Description: The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

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?
36252	Kinesiology ambulatory recorder	A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.	Active	false

FDA Product Code

[?]

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

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: 4dfefba9-6b23-470e-b631-7019a64e22a8
Public Version Date: March 05, 2020
Public Version Number: 2
DI Record Publish Date: August 10, 2018