AccessGUDID - DEVICE: LUX-Dx™ Insertable Cardiac Monitor (00802526607103)

GUDID

Device Identifier (DI) Information

Brand Name: LUX-Dx™ Insertable Cardiac Monitor
Version or Model: M301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60M301-102
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00802526607103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106295384 *Terms of Use

Device Description: LUX-Dx™ Insertable Cardiac Monitor

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
47804	Implantable cardiac monitor	A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.	Active	true

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: Yes
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: d424f4c6-1c56-440a-b773-4f18d6798912
Public Version Date: June 02, 2021
Public Version Number: 2
DI Record Publish Date: July 01, 2020