Catalog Number

1953588

Brand Name

Plum

Version/Model Number

1953588

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

d169d2bc-979e-4ce8-99c5-817e9259561f

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

May 31, 2018

Package DI Number

20887787008764

Quantity per Package

48

Contains DI Package

10887787008767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case