AccessGUDID - DEVICE: Advisor™ VL, Sensor Enabled™ (05415067027252)

GUDID

Device Identifier (DI) Information

Brand Name: Advisor™ VL, Sensor Enabled™
Version or Model: D-AVSE-D10-V1525
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D-AVSE-D10-V1525
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067027252
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Circular Mapping Catheter

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:	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?
46355	Cardiac mapping catheter, percutaneous, single-use	A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192037	000
K202066	000

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
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry, Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8.0000 French
Length: 117.0000 Centimeter

Device Record Status

Public Device Record Key: 0ebf16fe-0181-4784-8f43-3ae844f91038
Public Version Date: January 17, 2025
Public Version Number: 3
DI Record Publish Date: September 26, 2019