Catalog Number

-

Brand Name

IV Plus®

Version/Model Number

N0606

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

K080976,K080976

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

829756be-5789-4c29-905e-9281c8202308

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

30892855000813

Quantity per Package

50

Contains DI Package

10892855000819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-