Catalog Number

303370

Brand Name

N/A

Version/Model Number

303370

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

872101cf-c17b-4b98-a4c0-dd05915607d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

50382903033701

Quantity per Package

10

Contains DI Package

30382903033707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case