AccessGUDID - DEVICE: ACCUSYNC (00860008802057)

GUDID

Device Identifier (DI) Information

Brand Name: ACCUSYNC
Version or Model: 7200-5P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7200-5P
Company Name: Accusync Medical Research Corporation

Primary DI Number: 00860008802057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060000759 *Terms of Use

Device Description: ACCUSYNC 72 5 LEAD CARDIAC TRIGGER MONITOR WITH PRINTER OPTION

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):	No
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?
36561	Patient monitoring system module, cardiac output	A small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYY	Synchronizer, Electrocardiograph, Nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 34405ccb-842b-46df-aa3a-6e186b32aed1
Public Version Date: November 18, 2024
Public Version Number: 1
DI Record Publish Date: November 08, 2024