Catalog Number

-

Brand Name

Set Administration Intravascular

Version/Model Number

FL1002-FM

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

24279e60-d9a7-4543-8c99-fba1ef80310c

Public Version Date

June 25, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

10816513022579

Quantity per Package

100

Contains DI Package

00816513022572

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX