AccessGUDID - DEVICE: Viterion 100 TeleHealth Monitor (00852579007009)

GUDID

Device Identifier (DI) Information

Brand Name: Viterion 100 TeleHealth Monitor
Version or Model: 3.5.0.en
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 81842478
Company Name: VITERION CORPORATION

Primary DI Number: 00852579007009
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 078831113 *Terms of Use

Device Description: A convenient, easy-to-use, tabletop physiological monitoring system.

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:	Yes
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?
18118	Home healthcare information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of home healthcare services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

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

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
Weight: 3.800 Pound
Depth: 3.900 Inch
Width: 9.720 Inch
Height: 7.680 Inch

Device Record Status

Public Device Record Key: 567c55ea-15c6-4a5a-ae49-afefe718c128
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 17, 2016