Catalog Number

000475

Brand Name

Fluid Administration Set

Version/Model Number

000475

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"

-

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

-

Product Code

EYN

Product Code Name

Tray, Irrigation, Sterile

Public Device Record Key

471ea654-56d6-4225-8e72-10857d7f6f45

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

20815112020013

Quantity per Package

10

Contains DI Package

10815112020016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box