Catalog Number

-

Brand Name

PME014B

Version/Model Number

PME014B

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

15a31fd2-8ff0-485b-a8d3-850c4d577ca6

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Package DI Number

10850005864544

Quantity per Package

50

Contains DI Package

00850005864547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-