Catalog Number

197640

Brand Name

IV Line w/ Stopcock

Version/Model Number

197640

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

OJA

Product Code Name

Intravenous Extension Tubing Set

Public Device Record Key

b0108b7a-6e9d-4c2b-8636-76c657dcb2ef

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333208818

Quantity per Package

25

Contains DI Package

00886333208814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box