JiveX - Version 5.1 includes all minor versions and patch - VISUS Health IT GmbH

Duns Number:329645803

Device Description: Version 5.1 includes all minor versions and patch levels of 5.1

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More Product Details

Catalog Number

-

Brand Name

JiveX

Version/Model Number

5.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

f1933198-58f6-4651-8275-b424ae90e1dc

Public Version Date

May 23, 2019

Public Version Number

2

DI Record Publish Date

January 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISUS HEALTH IT GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3