AccessGUDID - DEVICE: VISITAG EXT PROCESSING UNIT ACCESS (10846835018585)

GUDID

Device Identifier (DI) Information

Brand Name: VISITAG EXT PROCESSING UNIT ACCESS
Version or Model: M665701SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M665701SP
Company Name: Biosense Webster Inc

Primary DI Number: 10846835018585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: DOCK, VISITAG SURPOINT EPU SP

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?
34972	Cardiac mapping system computer	A dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030031	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
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Do not use if package is opened
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b00f0a16-2547-4a9b-a3d9-51d1a90423e7
Public Version Date: February 10, 2022
Public Version Number: 2
DI Record Publish Date: October 14, 2021