AccessGUDID - DEVICE: myLUX™ Patient Kit with mobile device (00802526607363)

GUDID

Device Identifier (DI) Information

Brand Name: myLUX™ Patient Kit with mobile device
Version or Model: 666259-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 666259-100
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00802526607363
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106295384 *Terms of Use

Device Description: MyLUX(TM) Patient Kit with mobile device

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:	Yes
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 [?]
K193473	000

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: 228d4525-8848-4eba-9b40-d5f9ee900a3f
Public Version Date: July 09, 2020
Public Version Number: 1
DI Record Publish Date: July 01, 2020