Catalog Number

1284.000G

Brand Name

VYGON

Version/Model Number

1284.000G

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

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

3e788871-d11b-4efe-9b9a-d92d239067f7

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

February 28, 2018

Package DI Number

33660812075382

Quantity per Package

30

Contains DI Package

03660812075381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box