Catalog Number

IN7130/C

Brand Name

Blue Diamond™

Version/Model Number

00884450409855

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

bdd99e6d-a583-40b9-b500-38461403c3d5

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

February 25, 2020

Package DI Number

20884450409859

Quantity per Package

4

Contains DI Package

10884450409852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-