Catalog Number

-

Brand Name

PM007

Version/Model Number

PM007

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

fbce7979-1e0c-4116-87a3-b02e5329e14a

Public Version Date

July 31, 2019

Public Version Number

1

DI Record Publish Date

July 23, 2019

Package DI Number

10850005864537

Quantity per Package

50

Contains DI Package

00850005864530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-