Catalog Number

-

Brand Name

PMGF090NY

Version/Model Number

PMGF090NY

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

7aad2030-d80e-4912-a4aa-5665d9b6f902

Public Version Date

July 23, 2019

Public Version Number

1

DI Record Publish Date

July 15, 2019

Package DI Number

10850005864407

Quantity per Package

50

Contains DI Package

00850005864400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-