RIVA - A device used to prepare IV bags and syringes for - ARxIUM Inc

Duns Number:202676839

Device Description: A device used to prepare IV bags and syringes for hospital and compounding pharmacies.

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More Product Details

Catalog Number

CON-0100-9

Brand Name

RIVA

Version/Model Number

100000

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)

-

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

NEP

Product Code Name

System/Device, Pharmacy Compounding

Device Record Status

Public Device Record Key

815ac811-39b4-4a6e-9d74-0aacfb7442c2

Public Version Date

January 24, 2020

Public Version Number

4

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARXIUM INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1