Catalog Number

2B8014

Brand Name

INTRAVIA

Version/Model Number

2B8014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

K964853,K964853,K964853

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

e18bbc0d-6571-495a-99a8-a16d721a8843

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20085412000040

Quantity per Package

6

Contains DI Package

00085412000046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK