AccessGUDID - DEVICE: Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB (00817980020320)

GUDID

Device Identifier (DI) Information

Brand Name: Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB
Version or Model: ARCS Series S/W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A10-0122-01
Company Name: VASOMEDICAL, INC.

Primary DI Number: 00817980020320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197210248 *Terms of Use

Device Description: ARCS Software & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB

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 [?]
K092785	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ac5dbf9-a9ce-44a4-a7ac-f300b19b0c42
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016