Catalog Number

-

Brand Name

IV Plus

Version/Model Number

N0670

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

f9a93f93-01b1-4456-ab3b-f41ddf3506a5

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

30815879021398

Quantity per Package

100

Contains DI Package

10815879021394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-