FDA.report

Viterion 100 TeleHealth Monitor

Primary DI
00852579007009
Brand
Viterion 100 TeleHealth Monitor
Company
VITERION CORPORATION
Model
3.5.0.en
Catalog number
81842478
Device description
A convenient, easy-to-use, tabletop physiological monitoring system.
Published
2016-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications

CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10852579007006PackageGS15Not in Commercial Distribution
00852579007009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085257900700610852579007006
00852579007009008525790070098525790070090852579007009

GMDN Terms

TermDefinition
Home healthcare information systemA 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).

Device Sizes

TypeValueUnit
Height7.68Inch

Sterilization Methods

Method

Contacts

PhoneEmail
8008660133support@viterion.com

Regulatory Flags

DUNS number
078831113
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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