Catalog Number

IN7352/C

Brand Name

Blue Diamond™

Version/Model Number

00884450409879

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

731e023e-79be-4749-8609-f26802a8681c

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

20884450409873

Quantity per Package

4

Contains DI Package

10884450409876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-