Catalog Number

-

Brand Name

Set, Administration, Intravascular

Version/Model Number

BGI-BC593

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

497bce7f-45cf-45c6-adaf-e119df114e15

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

10816513023903

Quantity per Package

50

Contains DI Package

00816513023906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX