Catalog Number

-

Brand Name

Set, Administration, Intravascular

Version/Model Number

EA-006-01

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)

-

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

335b9f2e-6ca0-40e2-8365-cc92af8d116b

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

10816513024887

Quantity per Package

50

Contains DI Package

00816513024880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX