Catalog Number

399589A

Brand Name

Angio Procedure Pack

Version/Model Number

399589A

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

FNY

Product Code Name

Basin, Emesis

Public Device Record Key

bcec0c78-78eb-445a-bce9-f159d5db126a

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

20886333212815

Quantity per Package

10

Contains DI Package

00886333212811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box