Catalog Number

GO IO-F

Brand Name

GO IO

Version/Model Number

1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OJA

Product Code Name

Intravenous Extension Tubing Set

Public Device Record Key

089ae078-ddb0-4262-aee5-5e48590ab621

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

June 24, 2021

Package DI Number

10850026832119

Quantity per Package

12

Contains DI Package

00850026832112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX