Catalog Number

240020401

Brand Name

Plum

Version/Model Number

24002

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

5a585983-34e6-4fd8-ad7a-63ccdb17ea3b

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Package DI Number

10887709102030

Quantity per Package

50

Contains DI Package

00887709102033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box