Catalog Number

00580404

Brand Name

VYGON

Version/Model Number

5804.04

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

c10abc00-fffc-46d2-8912-69ce186cb518

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Package DI Number

33660812123076

Quantity per Package

50

Contains DI Package

03660812123075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box