AccessGUDID - DEVICE: myLUX™ Patient App (00802526623103)

GUDID

Device Identifier (DI) Information

Brand Name: myLUX™ Patient App
Version or Model: 622939-120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2939
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00802526623103
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 106295384 *Terms of Use

Device Description: for Insertable Cardiac Monitor

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61680	Implantable cardiac device management application software	An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXD	Recorder, event, implantable cardiac, (with arrhythmia detection)

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: a7b6e4cd-fd17-4fac-a969-b7e6d25c442f
Public Version Date: April 14, 2025
Public Version Number: 2
DI Record Publish Date: August 31, 2023