AccessGUDID - DEVICE: CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application (00763000754914)

GUDID

Device Identifier (DI) Information

Brand Name: CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application
Version or Model: D00U024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000754914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: SW D00U024 CARELINK SS LINQ II ICM

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):	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 [?]
K230553	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: 6ca747a1-8bab-41a4-9a9b-492ae0a904a5
Public Version Date: May 03, 2024
Public Version Number: 1
DI Record Publish Date: April 25, 2024