Catalog Number

1261.20N

Brand Name

VYGON

Version/Model Number

1261.20N

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

K954302,K954302,K954302

Product Code

LJS

Product Code Name

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

Public Device Record Key

676838f8-68af-4b55-8386-251074b4b70f

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 2020

Package DI Number

30849884002332

Quantity per Package

20

Contains DI Package

00849884002331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-