AccessGUDID - DEVICE: CareLink SmartSync™ (00643169868540)

GUDID

Device Identifier (DI) Information

Brand Name: CareLink SmartSync™
Version or Model: 24970A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169868540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: PROGRAMMER 24970A USA

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Implantable pacemaker analyser, intraoperative	An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.

GMDN Preferred Term Name

GMDN Definition

Implantable pacemaker analyser, intraoperative

An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.

FDA Product Code

[?]

Product Code	Product Code Name
DTC	ANALYZER, PACEMAKER GENERATOR FUNCTION
DTA	TESTER, PACEMAKER ELECTRODE FUNCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163008	000
P890003	406

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e1d0bdf-ab88-4fc6-8900-f0a8813a86af
Public Version Date: July 02, 2019
Public Version Number: 4
DI Record Publish Date: May 25, 2017