Catalog Number

-

Brand Name

Set, I.V. Fluid Transfer

Version/Model Number

2 PHARM-6

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K850757,K850757

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

6186898d-0f7f-4bc4-802d-4391f8dd1b1c

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

May 23, 2016

Package DI Number

10816513020254

Quantity per Package

40

Contains DI Package

00816513020257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX