Catalog Number

-

Brand Name

IV Plus

Version/Model Number

N9348M

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

f4e7c64e-8c8a-4bee-8558-a5b990c340d1

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 20, 2021

Package DI Number

30815879021299

Quantity per Package

25

Contains DI Package

10815879021295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-