Catalog Number

2400601

Brand Name

Plum

Version/Model Number

2400601

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141789,K141789

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

203c6965-a03f-40dd-bb0e-fbaf35d548c4

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

June 04, 2018

Package DI Number

20887787009211

Quantity per Package

50

Contains DI Package

10887787009214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box