AccessGUDID - DEVICE: Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor (00817980021396)

GUDID

Device Identifier (DI) Information

Brand Name: Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor
Version or Model: Model EZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A13-0040
Company Name: VASOMEDICAL, INC.

Primary DI Number: 00817980021396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197210248 *Terms of Use

Device Description: EZ™ Software CD & Data Cable for ECG Monitor

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?
41651	Electrocardiographic long-term ambulatory recording analyser application software	A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSH	RECORDER, MAGNETIC TAPE, MEDICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073152	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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d42d16d5-6333-4978-a041-d6246f9b5507
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016