Catalog Number

1955488

Brand Name

Plum

Version/Model Number

1955488

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

d06e8a35-8b9b-4a9a-b9fa-799a2410c8a5

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

20887787008771

Quantity per Package

48

Contains DI Package

10887787008774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case