Catalog Number

197644

Brand Name

Large Bore Vented IV Set

Version/Model Number

197644

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

1b6905a6-8e26-41af-a00e-c571798b1f50

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20886333208849

Quantity per Package

10

Contains DI Package

00886333208845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box